HEARTPORT ENDOAORTIC CLAMP CATHETER
FDA 510(k) clearance K974175 · decided 1997-12-16
Clearance details
- K-number
- K974175
- Device name
- HEARTPORT ENDOAORTIC CLAMP CATHETER
- Applicant
- Heartport, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-06
- Decision date
- 1997-12-16
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- DWZ
- Device class
- 2
- Regulation number
- 870.4075
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter recall (Z-0085-2010) | Edwards Lifesciences Research Medical, Inc. | 2009-11-06 |
| The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with recall (Z-0811-05) | Heartport, Inc. | 2005-05-10 |