The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Optiv Antage Dh Power Injection System.
| Device ID | K042744 |
| 510k Number | K042744 |
| Device Name: | OPTIV ANTAGE DH POWER INJECTION SYSTEM |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Ellis Rogers |
| Correspondent | Ellis Rogers MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2004-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20746190004261 | K042744 | 000 |
| 20746190002243 | K042744 | 000 |
| 20746190002250 | K042744 | 000 |
| 20746190002267 | K042744 | 000 |
| 20746190002304 | K042744 | 000 |
| 20746190002311 | K042744 | 000 |
| 30746190002325 | K042744 | 000 |
| 10746190003977 | K042744 | 000 |
| 10746190004240 | K042744 | 000 |
| 20746190004254 | K042744 | 000 |
| 20746190002229 | K042744 | 000 |