The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Modification To The Crosser System.
Device ID | K091119 |
510k Number | K091119 |
Device Name: | MODIFICATION TO THE CROSSER SYSTEM |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-17 |
Decision Date | 2009-05-15 |
Summary: | summary |