The following data is part of a premarket notification filed by Mallinckroot, Inc. with the FDA for Modified Softouch Introducer W/hemo Valve & Side.
| Device ID | K894445 |
| 510k Number | K894445 |
| Device Name: | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE |
| Classification | Introducer, Catheter |
| Applicant | MALLINCKROOT, INC. 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | David E Brown |
| Correspondent | David E Brown MALLINCKROOT, INC. 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 | 1989-07-17 |
| Decision Date | 1989-10-02 |