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 |