The following data is part of a premarket notification filed by Cryocath Technologies, Inc. with the FDA for Freezor Xtra Surgical Cardiac Cryoablation Device And Cct.2 Cardiac Cardiac Cryoablation Cryoconsole.
| Device ID | K030303 |
| 510k Number | K030303 |
| Device Name: | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CRYOCATH TECHNOLOGIES, INC. 16771 CHEMIN STE MARIE Kirkland, CA H9h 5h3 |
| Contact | Jean-pierre Desmarais |
| Correspondent | Jean-pierre Desmarais CRYOCATH TECHNOLOGIES, INC. 16771 CHEMIN STE MARIE Kirkland, CA H9h 5h3 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-29 |
| Decision Date | 2003-04-29 |
| Summary: | summary |