The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Vp Sheath.
Device ID | K051580 |
510k Number | K051580 |
Device Name: | VP SHEATH |
Classification | Catheter, Percutaneous |
Applicant | FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
Contact | Richard Spano |
Correspondent | Richard Spano 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 | 2005-06-15 |
Decision Date | 2005-10-31 |