NKU — Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed Class II
FDA product code NKU covers "Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed", a Class II medical device regulated under 21 CFR 870.1650. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- NKU
- Device Class
- Class II
- Regulation Number
- 870.1650
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053188 | sterilmed | REPROCESSED BALOON INFLATION DEVICE | May 4, 2006 |