The following data is part of a premarket notification filed by Mercator Medsystems, Inc. with the FDA for Blowfish Transbronchial Micro-infusion Catheter.
| Device ID | K131401 |
| 510k Number | K131401 |
| Device Name: | BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | MERCATOR MEDSYSTEMS, INC. 1670 ALVARADO SUITE #4 San Leandro, CA 94577 |
| Contact | Plamena Entcheva-dimitrov, Phd |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-05-15 |
| Decision Date | 2013-07-02 |
| Summary: | summary |