The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Safe-cross(r) Radio Frequency Total Occlusion Crossing System, Safe-cross(r) Radio Frequency Total Occlusion Crossing.
| Device ID | K073162 |
| 510k Number | K073162 |
| Device Name: | SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING |
| Classification | Wire, Guide, Catheter |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Robin Fatzinger |
| Correspondent | Robin Fatzinger KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-09 |
| Decision Date | 2008-02-08 |
| Summary: | summary |