AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
FDA 510(k) clearance K140382 · decided 2014-11-25
Clearance details
- K-number
- K140382
- Device name
- AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-14
- Decision date
- 2014-11-25
- Days to decision
- 284 days
- Clearance type
- Traditional
- Product code
- JCT
- Device class
- 2
- Regulation number
- 878.3720
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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