DST · Clip, Vena-Cava
Cardiovascular · 21 CFR 870.3260 · Class 2
Overview
| Product Code | DST |
|---|---|
| Device Name | Clip, Vena-Cava |
| Regulation | 21 CFR 870.3260 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K900207 | EPICARDIA 4000 | Medicomp, Inc. | Jul 31, 1990 | SESE |
Top Applicants
- Medicomp, Inc. — 1 clearance
