Company ยท US
Cryocath Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2008. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 27, 2008 | K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 Cryocath Technologies, Inc. | DRA |
| Dec 28, 2007 | K070357 | FLEXCATH STEERABLE SHEATH & DILATOR Cryocath Technologies, Inc. | DRA |
| Aug 24, 2006 | K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 Cryocath Technologies, Inc. | OCL |
| Jan 13, 2006 | K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc. | OCL |
| Apr 29, 2004 | K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE Cryocath Technologies, Inc., CA | OCL |
| Apr 29, 2003 | K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE Cryocath Technologies, Inc., CA | GEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2006 | CryoCath Technologies Inc. 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. Terminated |
LPB | None listed |