The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Softouch Guiding Catheter.
| Device ID | K905547 |
| 510k Number | K905547 |
| Device Name: | SOFTOUCH GUIDING CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | David E Brown |
| Correspondent | David E Brown MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-11 |
| Decision Date | 1991-02-05 |