SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT
Device Facts
| Record ID | K884159 |
|---|---|
| Device Name | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT |
| Applicant | Mallinckroot, Inc. |
| Product Code | DYB · Cardiovascular |
| Decision Date | Feb 22, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
