The following data is part of a premarket notification filed by Interventional Medical, Inc. with the FDA for Inflation Device.
| Device ID | K830609 |
| 510k Number | K830609 |
| Device Name: | INFLATION DEVICE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | INTERVENTIONAL MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-25 |
| Decision Date | 1983-03-24 |