The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Triactiv Fx Embolic Protection System, Model Pn 60040-02; -03.
| Device ID | K062870 |
| 510k Number | K062870 |
| Device Name: | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Robin M Fatzinger |
| Correspondent | Robin M Fatzinger KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2006-10-20 |
| Summary: | summary |