LXN · Probe, Test, Heart-Valve
Cardiovascular · 21 CFR 870.4500 · Class 1
Overview
| Product Code | LXN |
|---|---|
| Device Name | Probe, Test, Heart-Valve |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890165 | FORCEPS-ORTHOPEDIC | Dhason Brothers, Inc. | Feb 13, 1989 | SESE |
| K881449 | EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 | Baxter Healthcare Corp | Jun 15, 1988 | SESE |
Top Applicants
- Baxter Healthcare Corp — 1 clearance
- Dhason Brothers, Inc. — 1 clearance
