OFC · Catheter Introducer Kit
Cardiovascular · 21 CFR 870.1340 · Class 2
Overview
| Product Code | OFC |
|---|---|
| Device Name | Catheter Introducer Kit |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K093257 | TORQMAX SHEATH GRIP ACCESSORY | Spectranetics Corp. | Mar 26, 2010 | SESE |
Top Applicants
- Spectranetics Corp. — 1 clearance
