AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
FDA 510(k) clearance K020693 · decided 2002-09-05
Clearance details
- K-number
- K020693
- Device name
- AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
- Applicant
- Embol-X, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-03-04
- Decision date
- 2002-09-05
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- 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 |
|---|---|---|
| EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''. recall (Z-0306-05) | Edwards Lifesciences Research Medical Inc | 2004-12-15 |