The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Cryoflex Surgical Ablation System.
| Device ID | K123733 |
| 510k Number | K123733 |
| Device Name: | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MVS83 Mounds View, MN 55112 |
| Contact | Kari Christianson |
| Correspondent | Kari Christianson MEDTRONIC INC. 8200 CORAL SEA STREET NE MS MVS83 Mounds View, MN 55112 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-05 |
| Decision Date | 2013-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169305106 | K123733 | 000 |
| 00763000015008 | K123733 | 000 |
| 00763000015015 | K123733 | 000 |
| 00763000114619 | K123733 | 000 |
| 00763000114626 | K123733 | 000 |
| 00763000114633 | K123733 | 000 |
| 00763000114640 | K123733 | 000 |
| 00643169183841 | K123733 | 000 |
| 00643169183865 | K123733 | 000 |
| 00643169183889 | K123733 | 000 |
| 00763000014995 | K123733 | 000 |