510(k) K181200
K181200 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "AEROmini Tracheobronchial Stent System". The FDA issued a decision of Substantially Equivalent on September 21, 2018. The device falls under product code JCT (Prosthesis, Tracheal, Expandable), a Class II device regulated under 21 CFR 878.3720. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2018
- Date Received
- May 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type