510(k) K053436 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
| Applicant | Cryocath Technologies, Inc., Brookline MA, US |
| Decision | Substantially Equivalent, Jan 13, 2006 |
| Received | Dec 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053436
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2006 | ATS Medical, Inc. CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) pa Terminated |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.