The following data is part of a premarket notification filed by Cardio-pak with the FDA for Cardio-pak Angiography Custom Packs.
| Device ID | K902475 |
| 510k Number | K902475 |
| Device Name: | CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | CARDIO-PAK 1602 4TH AVE.NORTH Billings, MT 59101 |
| Contact | Jerome E Dernbach |
| Correspondent | Jerome E Dernbach CARDIO-PAK 1602 4TH AVE.NORTH Billings, MT 59101 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-12-03 |