NMI COAXIAL MICROINTRODUCER SET
FDA 510(k) clearance K132713 · decided 2013-09-27
Clearance details
- K-number
- K132713
- Device name
- NMI COAXIAL MICROINTRODUCER SET
- Applicant
- Navilyst Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-30
- Decision date
- 2013-09-27
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marlborough, MA, US
- Third-party review
- No
- Expedited review
- No
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