Bullfrog Micro-Infusion Device
FDA 510(k) clearance K161402 · decided 2016-08-18
Clearance details
- K-number
- K161402
- Device name
- Bullfrog Micro-Infusion Device
- Applicant
- Mercator Medsystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-05-20
- Decision date
- 2016-08-18
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- KRA
- Device class
- 2
- Regulation number
- 870.1210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Emeryville, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.