The following data is part of a premarket notification filed by Mercator Medsystems, Inc. with the FDA for Bullfrog Micro-infusion Device.
| Device ID | K161402 |
| 510k Number | K161402 |
| Device Name: | Bullfrog Micro-Infusion Device |
| Classification | Catheter, Continuous Flush |
| Applicant | MERCATOR MEDSYSTEMS, INC. 1900 POWELL STREET SUITE 800 Emeryville, CA 94608 |
| Contact | Kirk P. Seward |
| Correspondent | Adam Harris TARGET HEALTH INC. 261 MADISON AVE 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 | 2016-05-20 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M973BF102S1 | K161402 | 000 |
| M973BF102M1 | K161402 | 000 |
| M973BF102L1 | K161402 | 000 |
| M973BF102R1 | K161402 | 000 |