BioCardia 8F Morph DNA Deflectable Guide Catheter
FDA 510(k) clearance K192774 · decided 2020-01-07
Clearance details
- K-number
- K192774
- Device name
- BioCardia 8F Morph DNA Deflectable Guide Catheter
- Applicant
- Biocardia
- Decision
- Substantially Equivalent
- Date received
- 2019-09-30
- Decision date
- 2020-01-07
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.