The following data is part of a premarket notification filed by Mercator Medsystems, Inc. with the FDA for Bullfrog Micro-infusion Device.
| Device ID | K153501 |
| 510k Number | K153501 |
| Device Name: | Bullfrog Micro-Infusion Device |
| Classification | Catheter, Continuous Flush |
| Applicant | MERCATOR MEDSYSTEMS, INC. 2200 POWELL STREET SUITE 530 Emeryville, CA 94608 |
| Contact | Kirk P. Seward |
| Correspondent | Adam Harris TARGET HEALTH, INC. 261 MADISON AVENUE 24TH FLOOR New York, NY 10016 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-04-15 |
| Summary: | summary |