Angel Catheter
FDA 510(k) clearance K160747 · decided 2016-07-28
Clearance details
- K-number
- K160747
- Device name
- Angel Catheter
- Applicant
- Bio2 Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-18
- Decision date
- 2016-07-28
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- PNS
- Device class
- 2
- Regulation number
- 870.3375
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio2 Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.