MACROPORE CARDIO-WRAP (TS)
FDA 510(k) clearance K031785 · decided 2003-09-04
Clearance details
- K-number
- K031785
- Device name
- MACROPORE CARDIO-WRAP (TS)
- Applicant
- Macropore Biosurgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-10
- Decision date
- 2003-09-04
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- OMH
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.