PNS — Short-Term Intravascular Filter Catheter Class II
FDA product code PNS covers "Short-Term Intravascular Filter Catheter", a Class II medical device regulated under 21 CFR 870.3375. 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
- PNS
- Device Class
- Class II
- Regulation Number
- 870.3375
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
For short-term prevention of pulmonary embolism (PE)
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K160747 | bio2 medical | Angel Catheter | July 28, 2016 |