PNQ — Apical Closure Device Class II
FDA product code PNQ covers "Apical Closure Device", a Class II medical device regulated under 21 CFR 870.4510. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PNQ
- Device Class
- Class II
- Regulation Number
- 870.4510
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
This device is intended for closure of cardiac apical tissue.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN150029 | micro interventional devices | Permaseal | July 27, 2016 |