DXP · Transducer, Vessel Occlusion
Cardiovascular · 21 CFR 870.2890 · Class 2
Overview
| Product Code | DXP |
|---|---|
| Device Name | Transducer, Vessel Occlusion |
| Regulation | 21 CFR 870.2890 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891180 | TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT | Ingress Technologies, Inc. | Jun 15, 1989 | SESE |
| K812639 | UNICUFF | Frontier Products | Oct 2, 1981 | SESE |
Top Applicants
- Frontier Products — 1 clearance
- Ingress Technologies, Inc. — 1 clearance
