The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for The Crosser S6 Catheter, The Crosser System Electronics, Model Crus6, Gen200.
Device ID | K092175 |
510k Number | K092175 |
Device Name: | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 |
Classification | Catheter For Crossing Total Occlusions |
Applicant | FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
Contact | Dustin Michaels |
Correspondent | Dustin Michaels FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
Product Code | PDU |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-07-21 |
Decision Date | 2010-02-17 |
Summary: | summary |