The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Heparin-coated Balloon Thermodilut.
| Device ID | K833572 |
| 510k Number | K833572 |
| Device Name: | HEPARIN-COATED BALLOON THERMODILUT |
| Classification | Catheter, Flow Directed |
| Applicant | CRITIKON COMPANY,LLC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-12 |
| Decision Date | 1984-01-30 |