PNQClass II
Apical Closure Device
21 CFR 870.4510 / Cardiovascular
PNQ is the FDA product code for Apical Closure Device, a class II device type, regulated under 21 CFR 870.4510. FDA's definition for this code reads: "This device is intended for closure of cardiac apical tissue". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PNQ
- Device name
- Apical Closure Device
- FDA definition
- This device is intended for closure of cardiac apical tissue.
- Regulation
- 21 CFR 870.4510
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PNQ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 1 |
Applicants with the most clearances
Product code PNQ| Applicant | Clearances |
|---|---|
| Micro Interventional Devices,Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PNQ.
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