510(k) K160747
K160747 is an FDA 510(k) premarket notification submitted by Bio2 Medical, Inc. for the device "Angel Catheter". The FDA issued a decision of Substantially Equivalent on July 28, 2016. The device falls under product code PNS (Short-Term Intravascular Filter Catheter), a Class II device regulated under 21 CFR 870.3375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2016
- Date Received
- March 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Short-Term Intravascular Filter Catheter
- Device Class
- Class II
- Regulation Number
- 870.3375
- Review Panel
- CV
- Submission Type
For short-term prevention of pulmonary embolism (PE)