The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Angiomat 6000.
| Device ID | K860204 |
| 510k Number | K860204 |
| Device Name: | ANGIOMAT 6000 |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | James S Adams |
| Correspondent | James S Adams MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-22 |
| Decision Date | 1986-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190004219 | K860204 | 000 |
| 20746190002021 | K860204 | 000 |
| 10746190002017 | K860204 | 000 |