The following data is part of a premarket notification filed by Cardiovascular Innovations with the FDA for Oz Power Syringe.
| Device ID | K973334 |
| 510k Number | K973334 |
| Device Name: | OZ POWER SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | CARDIOVASCULAR INNOVATIONS 4331 ARCARDY Dallas, TX 75205 |
| Contact | Azam Anwar |
| Correspondent | Azam Anwar CARDIOVASCULAR INNOVATIONS 4331 ARCARDY Dallas, TX 75205 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-04 |
| Decision Date | 1998-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102556 | K973334 | 000 |