Steerable Guide Catheter
FDA 510(k) clearance K161985 · decided 2016-08-07
Clearance details
- K-number
- K161985
- Device name
- Steerable Guide Catheter
- Applicant
- Abbott Vascular
- Decision
- Substantially Equivalent
- Date received
- 2016-07-19
- Decision date
- 2016-08-07
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- DRA
- Device class
- 2
- Regulation number
- 870.1280
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RX Herculink Elite (P110001/S022) | Abbott Vascular | 2025-10-22 |
| RX Acculink (P040012/S066) | Abbott Vascular | 2025-10-22 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine OTW) (P110019/S137) | Abbott Vascular | 2025-10-22 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine); XIENCE Sierra Everolimus Eluting Coronary Sten (P110019/S136) | Abbott Vascular | 2025-08-16 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S021) | Abbott Vascular | 2025-07-02 |
| Xience Skypoint Everolimus Eluting Coronary Stent System; XIENCE Alpine Everolimus Coronary Stent System; XIENCE Sierra (P110019/S135) | Abbott Vascular | 2025-05-19 |
| RX Acculink Carotid Stent System (P040012/S065) | Abbott Vascular | 2025-02-20 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S134) | Abbott Vascular | 2024-10-24 |