Athletis™
- Primary DI
- 08714729973676
- Brand
- Athletis™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- H74939347050470
- Catalog number
- H74939347050470
- 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 |
|---|---|---|---|---|
| 08714729973676 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 08714729973676 | 08714729973676 | 8714729973676 |
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 | 40 | 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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|---|---|---|---|---|
| 00191506004583 | WATCHMAN FLX™ Pro | M635WU60200 | M635WU60200 | 2023-09-12 |
| 00191506004590 | WATCHMAN FLX™ Pro | M635WU60240 | M635WU60240 | 2023-09-12 |
| 00191506004606 | WATCHMAN FLX™ Pro | M635WU60270 | M635WU60270 | 2023-09-12 |
| 00191506004613 | WATCHMAN FLX™ Pro | M635WU60310 | M635WU60310 | 2023-09-12 |
| 00191506004620 | WATCHMAN FLX™ Pro | M635WU60350 | M635WU60350 | 2023-09-12 |
| 00191506004637 | WATCHMAN FLX™ Pro | M635WU60400 | M635WU60400 | 2023-09-12 |
| 08714729195573 | RotaWire™ and wireClip™ Torquer | H802232390010 | H802232390010 | 2014-09-24 |
| 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 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640119558639 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558646 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558653 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558660 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558677 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558684 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558691 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558707 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558714 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558721 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558738 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558745 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558752 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558769 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558776 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558783 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558790 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558806 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558813 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558820 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558837 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558844 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558851 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558868 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558875 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558882 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558899 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558905 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558912 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558929 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |