The following data is part of a premarket notification filed by Cardiovascular Diagnostic Services with the FDA for Dorros-spring Pressurizer.
| Device ID | K812304 |
| 510k Number | K812304 |
| Device Name: | DORROS-SPRING PRESSURIZER |
| Classification | Syringe, Balloon Inflation |
| Applicant | CARDIOVASCULAR DIAGNOSTIC SERVICES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-18 |
| Decision Date | 1981-10-13 |