The following data is part of a premarket notification filed by Endocare, Inc. with the FDA for Modified Cardiac Cryosurgical System, Models 6tcs1 & 6tcse.
| Device ID | K021010 |
| 510k Number | K021010 |
| Device Name: | MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon ENDOCARE, INC. 7 STUDEBAKER Irvine, CA 92618 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-29 |
| Decision Date | 2002-06-06 |
| Summary: | summary |