MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
FDA 510(k) clearance K030476 · decided 2003-03-11
Clearance details
- K-number
- K030476
- Device name
- MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-13
- Decision date
- 2003-03-11
- Days to decision
- 26 days
- Clearance type
- Special
- 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 |
|---|---|---|
| Concentric brand Concentric Retriever X5 Percutaneous Catheter Model REF 90035 recall (Z-0085-04) | Concentric Medical Inc | 2004-07-20 |
| Concentric brand Concentric Retriever X6 Percutaneous Catheter Model REF 90037 recall (Z-0086-04) | Concentric Medical Inc | 2004-07-20 |