Athletis™
- Primary DI
- 08714729973645
- Brand
- Athletis™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H74939347050270
- Catalog number
- H74939347050270
- Device description
- PTA Balloon Dilatation Catheter
- Published
- 2020-10-07
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| LIT | Catheter, angioplasty, peripheral, transluminal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 08714729973645 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729973645 | 08714729973645 | 8714729973645 |
GMDN Terms
| Term | Definition |
|---|---|
| Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|---|---|
| Balloon Diameter | 5 | Millimeter |
| Balloon Length | 20 | Millimeter |
| Catheter Length | 75 | Centimeter |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|---|---|---|---|
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| 08714729195566 | RotaWire™ and wireClip™ Torquer | H802228240020 | H802228240020 | 2014-09-24 |
| 08714729837527 | Stingray™ | H749M3004A0 | 2016-09-24 | |
| 08714729877523 | EP XT™ | M0042007720 | M0042007720 | 2016-09-24 |
| 08714729877714 | Dynamic XT™ | M0042011120 | M0042011120 | 2016-09-24 |
| 08714729879947 | EP XT™ | M0046EPXT00390 | M0046EPXT00390 | 2016-09-24 |
| 08714729181088 | Percuflex™ Biliary | M00533760 | 2015-09-24 | |
| 08714729181095 | Percuflex™ Biliary | M00533770 | 2015-09-24 | |
| 08714729181101 | Percuflex™ Biliary | M00533780 | 2015-09-24 | |
| 08714729181118 | Percuflex™ Biliary | M00533790 | 2015-09-24 | |
| 08714729181125 | Percuflex™ Biliary | M00533800 | 2015-09-24 | |
| 08714729181132 | Percuflex™ Biliary | M00533810 | 2015-09-24 | |
| 08714729181149 | Percuflex™ Biliary | M00533820 | 2015-09-24 | |
| 08714729181156 | Percuflex™ Biliary | M00533830 | 2015-09-24 | |
| 08714729181163 | Percuflex™ Biliary | M00533850 | 2015-09-24 | |
| 08714729181217 | Percuflex™ Biliary | M00533610 | 2015-09-24 | |
| 08714729181224 | Percuflex™ Biliary | M00533620 | 2015-09-24 | |
| 08714729181231 | Percuflex™ Biliary | M00533630 | 2015-09-24 | |
| 08714729181248 | Percuflex™ Biliary | M00533640 | 2015-09-24 | |
| 08714729181255 | Percuflex™ Biliary | M00533650 | 2015-09-24 |
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| 06091403562749 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562756 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562763 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562770 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562787 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562794 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562800 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562817 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562824 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562831 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562848 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562855 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562862 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562879 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
| 06091403562886 | Amethyst HP PTA OTW 0.035" catheter | NATEC MEDICAL LTD | LIT | 2026-01-29 |
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