AngioSculpt® 2333-8040
GUDID 00813132022228
AngioSculpt® PTA Scoring Balloon Catheter
Spectranetics Corporation
Peripheral angioplasty balloon catheter, basic| Primary Device ID | 00813132022228 |
| NIH Device Record Key | 7e535442-5331-41ec-8175-6323e6fc053e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioSculpt® |
| Version Model Number | 2333-8040 |
| Catalog Number | 2333-8040 |
| Company DUNS | 151047370 |
| Company Name | Spectranetics Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Outer Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
| Balloon Length | 40 Millimeter |
| Balloon Diameter | 8 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813132022228 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150634
FDA Product Code
| PNO | Catheter, Percutaneous, Cutting/Scoring |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132022228]
Ethylene Oxide
[00813132022228]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [AngioSculpt®]
| 00813132022952 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022945 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022938 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022921 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022914 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022907 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022891 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022846 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022839 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022822 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132022242 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132022235 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132022228 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132022211 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132022204 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132022198 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021955 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021948 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021931 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021924 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021887 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021603 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021597 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021580 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021573 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132021566 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132021559 | AngioSculpt® PTA Scoring Balloon Catheter with HydroCross Coating |
| 00813132021542 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021535 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021528 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021511 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021504 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021498 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021450 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021443 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021436 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021429 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021412 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021405 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021399 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021382 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021375 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021368 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021351 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021344 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021337 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021320 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021313 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021306 | AngioSculpt® PTA Scoring Balloon Catheter |
| 00813132021290 | AngioSculpt® PTA Scoring Balloon Catheter |
Trademark Results [AngioSculpt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIOSCULPT 78263821 2920010 Live/Registered |
AngioScore, Inc. 2003-06-18 |
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