CONCENTRIC RETRIEVER, MODEL 90030
FDA 510(k) clearance K003410 · decided 2001-05-22
Clearance details
- K-number
- K003410
- Device name
- CONCENTRIC RETRIEVER, MODEL 90030
- Applicant
- Concentric Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-02
- Decision date
- 2001-05-22
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Moutian View, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Concentric Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |