Stellarex AB35SX060040135
GUDID 00810060550304
Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm
Philips Image Guided Therapy Corporation
Peripheral angioplasty balloon catheter, drug-coated| Primary Device ID | 00810060550304 |
| NIH Device Record Key | 74772a19-a931-4483-814b-54176ab5ee90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stellarex |
| Version Model Number | AB35SX060040135-B |
| Catalog Number | AB35SX060040135 |
| Company DUNS | 118354223 |
| Company Name | Philips Image Guided Therapy 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 | true |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
| Balloon Diameter | 6 Millimeter |
| Balloon Length | 40 Millimeter |
| Catheter Length | 135 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810060550304 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160049
FDA Product Code
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-17 |
| Device Publish Date | 2022-12-30 |
On-Brand Devices [Stellarex]
| 00813132028824 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm |
| 00810060550427 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 135cm |
| 00810060550410 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 200mm) x 80cm |
| 00810060550403 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 135cm |
| 00810060550397 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 150mm) x 80cm |
| 00810060550380 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 135cm |
| 00810060550373 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 120mm) x 80cm |
| 00810060550366 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 135cm |
| 00810060550359 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 100mm) x 80cm |
| 00810060550342 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 135cm |
| 00810060550335 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 80mm) x 80cm |
| 00810060550328 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 135cm |
| 00810060550311 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 60mm) x 80cm |
| 00810060550304 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 135cm |
| 00810060550298 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (6mm x 40mm) x 80cm |
| 00810060550281 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 135cm |
| 00810060550274 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 200mm) x 80cm |
| 00810060550267 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 135cm |
| 00810060550250 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 150mm) x 80cm |
| 00810060550243 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 135cm |
| 00810060550236 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 120mm) x 80cm |
| 00810060550229 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 135cm |
| 00810060550212 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 100mm) x 80cm |
| 00810060550205 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 135cm |
| 00810060550199 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 80mm) x 80cm |
| 00810060550182 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 135cm |
| 00810060550175 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 60mm) x 80cm |
| 00810060550168 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 135cm |
| 00810060550151 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (5mm x 40mm) x 80cm |
| 00810060550144 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 135cm |
| 00810060550137 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 200mm) x 80cm |
| 00810060550120 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 135cm |
| 00810060550113 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 150mm) x 80cm |
| 00810060550106 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 135cm |
| 00810060550090 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 120mm) x 80cm |
| 00810060550083 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 135cm |
| 00810060550076 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 100mm) x 80cm |
| 00810060550069 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 135cm |
| 00810060550052 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 80mm) x 80cm |
| 00810060550045 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 135cm |
| 00810060550038 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 60mm) x 80cm |
| 00810060550021 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 135cm |
| 00810060550014 | Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (4mm x 40mm) x 80cm |
Trademark Results [Stellarex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STELLAREX 98281976 not registered Live/Pending |
Pitcher, Charles Spencer 2023-11-22 |
 STELLAREX 85958731 4993727 Live/Registered |
Covidien LP 2013-06-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.