BYZ · Trap, Sterile Specimen
General Hospital · 21 CFR 880.6740 · Class 2
Overview
| Product Code | BYZ |
|---|---|
| Device Name | Trap, Sterile Specimen |
| Regulation | 21 CFR 880.6740 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | Electromedics, Inc. | Feb 5, 1993 | SESE |
| K913643 | MUCOUS SPECIMEN TRAP | Medical Device Inspection Co., Inc. | Oct 10, 1991 | SESE |
| K902883 | TISSUE/POLYP TRAP SYSTEM | Triton Technology, Inc. | Sep 12, 1990 | SESE |
| K841409 | BUSH NECK W/PLUG | Warne Surgical Products, Ltd. | Apr 18, 1984 | SESE |
| K840253 | ONE-WAY AIR VALVE | Delta Medical Industries | Apr 5, 1984 | SESE |
| K834467 | SPECIMEN TRAP | Microvasive | Feb 17, 1984 | SESE |
| K822557 | SPECIMEN ADAPTOR | Bemis Health Care | Oct 18, 1982 | SESE |
| K822556 | CRITICAL MEASUREMENT UNIT | Bemis Health Care | Oct 18, 1982 | SESE |
| K791847 | ASPRI-LUKE | Medical Marketing Group | Oct 2, 1979 | SESE |
Top Applicants
- Bemis Health Care — 2 clearances
- Delta Medical Industries — 1 clearance
- Electromedics, Inc. — 1 clearance
- Medical Device Inspection Co., Inc. — 1 clearance
- Medical Marketing Group — 1 clearance
