Angel Catheter— 510(k) K160747
Substantially EquivalentBio2 Medical, Inc.
FDA 510(k) clearance K160747 for Angel Catheter, Substantially Equivalent on 2016-07-28. Applicant: Bio2 Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio2 Medical, Inc.
- Product code
- Code PNS
- Device class
- Class 2
- Regulation
- 21 CFR 870.3375
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Golden, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.