Trap, Sterile Specimen
The Trap, Sterile Specimen is a sterile inline trap device placed in a suction circuit between the suction catheter and the collection container to capture respiratory or other biological specimens for microbiological or cytological analysis during suctioning. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BYZ, regulated under 21 CFR 880.6740 in the General Hospital specialty.
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Basic Information
- Product Code
- BYZ
- Device Class
- FDA class 2
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925412 | ELECTROMEDICS TISSUE TRAP/ #TT280 | Feb 05, 1993 | Substantially Equivalent | Electromedics, Inc. |
| K913643 | MUCOUS SPECIMEN TRAP | Oct 10, 1991 | Substantially Equivalent | Medical Device Inspection Co., Inc. |
| K902883 | TISSUE/POLYP TRAP SYSTEM | Sep 12, 1990 | Substantially Equivalent | Triton Technology, Inc. |
| K841409 | BUSH NECK W/PLUG | Apr 18, 1984 | Substantially Equivalent | Warne Surgical Products, Ltd. |
| K840253 | ONE-WAY AIR VALVE | Apr 05, 1984 | Substantially Equivalent | Delta Medical Industries |
| K834467 | SPECIMEN TRAP | Feb 17, 1984 | Substantially Equivalent | Microvasive |
| K822557 | SPECIMEN ADAPTOR | Oct 18, 1982 | Substantially Equivalent | Bemis Health Care |
| K822556 | CRITICAL MEASUREMENT UNIT | Oct 18, 1982 | Substantially Equivalent | Bemis Health Care |
| K791847 | ASPRI-LUKE | Oct 02, 1979 | Substantially Equivalent | Medical Marketing Group |
FEI Numbers
This FDA classification entry is associated with 64 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 64 registration numbers. Click on an entry to view related FDA registrations.