The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Microsheath Lp And Lp-at.
Device ID | K080849 |
510k Number | K080849 |
Device Name: | MICROSHEATH LP AND LP-AT |
Classification | Catheter, Percutaneous |
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 | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-03-26 |
Decision Date | 2008-07-25 |
Summary: | summary |