The following data is part of a premarket notification filed by Sentreheart Inc. with the FDA for Findrwirz Guide Wire System.
| Device ID | K080364 |
| 510k Number | K080364 |
| Device Name: | FINDRWIRZ GUIDE WIRE SYSTEM |
| Classification | Wire, Guide, Catheter |
| Applicant | SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie SENTREHEART INC. 2468 EMBARCADERO WAY Palo Alto, CA 94303 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-11 |
| Decision Date | 2008-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818354017588 | K080364 | 000 |
| 10840143901751 | K080364 | 000 |
| 30840143909522 | K080364 | 000 |