The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Softtouch Guide Catheter.
| Device ID | K934685 |
| 510k Number | K934685 |
| Device Name: | SOFTTOUCH GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Robert F Ingham |
| Correspondent | Robert F Ingham 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 | 1993-09-30 |
| Decision Date | 1994-04-07 |