AngioSculpt®PTCA Scoring Balloon Catheter
GUDID 00813132022037
Spectranetics Corporation
Coronary angioplasty balloon catheter, basic| Primary Device ID | 00813132022037 |
| NIH Device Record Key | 38dd2e58-4501-4792-9fea-00e37963631c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AngioSculpt®PTCA Scoring Balloon Catheter |
| Version Model Number | 2200-2020 |
| 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 | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Outer Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
| Balloon Diameter | 2 Millimeter |
| Balloon Length | 20 Millimeter |
Operating and Storage Conditions
| 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 | 00813132022037 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P050018
FDA Product Code
| NWX | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
[00813132022037]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2015-03-09 |
On-Brand Devices [AngioSculpt®PTCA Scoring Balloon Catheter]
| 00813132022181 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022174 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022167 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022150 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022143 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022136 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022129 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022112 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022105 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022099 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022082 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022075 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132022068 | 2200-3520 |
| 00813132022051 | 2200-3020 |
| 00813132022044 | 2200-2520 |
| 00813132022037 | 2200-2020 |
| 00813132021245 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021238 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021221 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021214 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021207 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021191 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021184 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021177 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021160 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021153 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021146 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021139 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021122 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021115 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021108 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021092 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021085 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021078 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021061 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021054 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021047 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021030 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021023 | AngioSculpt® PTCA Scoring Balloon Catheter |
| 00813132021016 | AngioSculpt® PTCA Scoring Balloon Catheter |
Trademark Results [AngioSculpt]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANGIOSCULPT 78263821 2920010 Live/Registered |
AngioScore, Inc. 2003-06-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.