EMBOLECTOMY CATHETER
FDA 510(k) clearance K902327 · decided 1991-02-25
Clearance details
- K-number
- K902327
- Device name
- EMBOLECTOMY CATHETER
- Applicant
- Clincal Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-24
- Decision date
- 1991-02-25
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- DXE
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Dudley, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, recall (Z-1471-2009) | Arrow International Inc | 2009-06-25 |
| Arrow Embolectomy Catheters: 5 French, 2 Lumen x 80cm, Product Number: W01801, Single use, recall (Z-1472-2009) | Arrow International Inc | 2009-06-25 |
| Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, Single use, recall (Z-1473-2009) | Arrow International Inc | 2009-06-25 |