The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Vp Wire Gw140st (.014 165cm, Standar), Model Gw140st; Vp Wire Gw140so (.014 165cm, Soft) Model Gw140so.
Device ID | K051062 |
510k Number | K051062 |
Device Name: | VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO |
Classification | Wire, Guide, Catheter |
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 | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-26 |
Decision Date | 2005-07-15 |
Summary: | summary |