The following data is part of a premarket notification filed by Mallinckrodt Inc., Liebel-flarsheim Business with the FDA for Angiomat Illumena.
| Device ID | K963071 |
| 510k Number | K963071 |
| Device Name: | ANGIOMAT ILLUMENA |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS 2111 EAST GALBRAITH RD. Cincinnati, OH 45237 |
| Contact | Bridget Drake |
| Correspondent | Bridget Drake 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10746190004882 | K963071 | 000 |
| 10746190002802 | K963071 | 000 |
| 10746190002796 | K963071 | 000 |
| 10746190002611 | K963071 | 000 |
| 10746190002604 | K963071 | 000 |
| 10746190002574 | K963071 | 000 |
| 10746190002567 | K963071 | 000 |
| 10746190002550 | K963071 | 000 |
| 20746190002373 | K963071 | 000 |
| 30746190002356 | K963071 | 000 |
| 10746190004042 | K963071 | 000 |
| 10746190004059 | K963071 | 000 |
| 10746190004066 | K963071 | 000 |
| 10746190004875 | K963071 | 000 |
| 10746190004868 | K963071 | 000 |
| 10746190004851 | K963071 | 000 |
| 10746190004844 | K963071 | 000 |
| 10746190004837 | K963071 | 000 |
| 10746190004288 | K963071 | 000 |
| 20746190004278 | K963071 | 000 |
| 10746190004080 | K963071 | 000 |
| 10746190004073 | K963071 | 000 |
| 20746190002335 | K963071 | 000 |