Angel Catheter
FDA 510(k) K160747 · Bio2 Medical, Inc.
510(k) numberK160747
Submission
- Device name
- Angel Catheter
- Applicant
- Bio2 Medical, Inc.
Golden, CO, US - Received
- March 18, 2016
- Decision date
- July 28, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNS – Short-Term Intravascular Filter Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3375
- Specialty
- Cardiovascular
- Implant
- Yes
For short-term prevention of pulmonary embolism (PE)
Questions and answers
When was Angel Catheter cleared by the FDA?
Angel Catheter (K160747) received a 510(k) decision of Substantially Equivalent on July 28, 2016, 132 days after the submission was received.
What is the product code of K160747?
The FDA product code is PNS – Short-Term Intravascular Filter Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.3375.