The following data is part of a premarket notification filed by Mercator Medsystems, Inc. with the FDA for Bullfrog Micro-infusion Device.
| Device ID | K210339 |
| 510k Number | K210339 |
| 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 | Kirk P. Seward Mercator MedSystems, Inc. 1900 Powell Street Suite 800 Emeryville, CA 94608 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-05 |
| Decision Date | 2021-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M973BF102P18 | K210339 | 000 |