The following data is part of a premarket notification filed by Mallinckrodt Group, Inc. with the FDA for Lf Ct Hig Pressure Catheters.
| Device ID | K945053 |
| 510k Number | K945053 |
| Device Name: | LF CT HIG PRESSURE CATHETERS |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Contact | M L Friedman |
| Correspondent | M L Friedman MALLINCKRODT GROUP, INC. 2111 EAST GALBRAITH RD. P.O. BOX 156305 Cincinnati, OH 45215 -6305 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-05-19 |