The following data is part of a premarket notification filed by Mallinckroot, Inc. with the FDA for Softouch Introducer W/hemostasis Valve & Sideport.
| Device ID | K884159 |
| 510k Number | K884159 |
| Device Name: | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT |
| Classification | Introducer, Catheter |
| Applicant | MALLINCKROOT, INC. 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Robert S Lake |
| Correspondent | Robert S Lake 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 | 1988-10-04 |
| Decision Date | 1989-02-22 |