The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Percutaneous Angiographic Needles.
| Device ID | K845037 |
| 510k Number | K845037 |
| Device Name: | PERCUTANEOUS ANGIOGRAPHIC NEEDLES |
| Classification | Introducer, Catheter |
| Applicant | MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Contact | Thomas W Tusing |
| Correspondent | Thomas W Tusing MALLINCKRODT CRITICAL CARE 675 MCDONNELL BLVD. P.O. BOX 5840 St Louis, MO 63134 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-06-21 |