The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Heparin-coated Cardiovascular.
| Device ID | K843141 |
| 510k Number | K843141 |
| Device Name: | CRITIKON HEPARIN-COATED CARDIOVASCULAR |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-09 |
| Decision Date | 1984-09-04 |