The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Cardioblate Cryoflex Surgical Ablation Probes.
| Device ID | K121878 |
| 510k Number | K121878 |
| Device Name: | CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES |
| Classification | Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue |
| Applicant | MEDTRONIC INC. 8200 CORAL SEA STREET NE MAIL STOP MVS83 Mounds View, MN 55112 |
| Contact | Kari Christianson |
| Correspondent | Kari Christianson MEDTRONIC INC. 8200 CORAL SEA STREET NE MAIL STOP MVS83 Mounds View, MN 55112 |
| Product Code | OCL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-28 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169183834 | K121878 | 000 |
| 00643169183827 | K121878 | 000 |
| 00643169183803 | K121878 | 000 |
| 00643169183780 | K121878 | 000 |
| 00643169183773 | K121878 | 000 |
| 00643169183759 | K121878 | 000 |
| 00763000014988 | K121878 | 000 |