MODIFIED HD GUIDE CATHETER
FDA 510(k) clearance K133177 · decided 2014-02-25
Clearance details
- K-number
- K133177
- Device name
- MODIFIED HD GUIDE CATHETER
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-17
- Decision date
- 2014-02-25
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DAC 044 115cm, Catalog: 90760 recall (Z-1908-2024) | Stryker Neurovascular | 2024-05-28 |
| The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter w recall (Z-1740-2024) | Stryker Neurovascular | 2024-05-01 |
| Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardio recall (Z-0116-2016) | Concentric Medical Inc | 2015-10-09 |