The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Cryocare Cardiac Surgical System.
| Device ID | K011040 |
| 510k Number | K011040 |
| Device Name: | CRYOCARE CARDIAC SURGICAL SYSTEM |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-05 |
| Decision Date | 2001-06-15 |