The following data is part of a premarket notification filed by Bio2 Medical, Inc. with the FDA for Angel Catheter.
| Device ID | K160747 |
| 510k Number | K160747 |
| Device Name: | Angel Catheter |
| Classification | Short-term Intravascular Filter Catheter |
| Applicant | BIO2 MEDICAL, INC. 4670 TABLE MOUNTAIN DRIVE Golden, CO 80403 |
| Contact | Christopher E. Banas |
| Correspondent | Julie Ross BIO2 MEDICAL, INC. 4670 TABLE MOUNTAIN DRIVE Golden, CO 80403 |
| Product Code | PNS |
| CFR Regulation Number | 870.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-18 |
| Decision Date | 2016-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B077AC3930A1 | K160747 | 000 |
| 15711055005002 | K160747 | 000 |