Needle, Biopsy, Cardiovascular
The Cardiovascular Biopsy Needle is a surgical device used to obtain small tissue samples from cardiovascular structures, such as the myocardium or pericardium, for histological examination and diagnostic evaluation. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DWO and it is regulated under 21 CFR 878.4800 within the General, Plastic Surgery medical specialty.
Basic Information
- Product Code
- DWO
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933364 | PROMED BIOPSY NEEDLE | Feb 15, 1994 | Substantially Equivalent | Vlv Associates, Inc. |
| K921418 | ULTRA-CORE BIOPSY NEEDLES | Jun 19, 1992 | Substantially Equivalent | Medical Device Technologies, Inc. |
| K913815 | AUTOMATED BIOPSY DEVICE, MODIFICATION | Oct 30, 1991 | Substantially Equivalent | Hart Enterprises, Inc. |
| K890925 | MANAN BONE MARROW BIOPSY NEEDLE | Apr 11, 1989 | Substantially Equivalent | Manan Medical Products, Inc. |
| K885145 | MEDSURG GREENE NEEDLE | Mar 14, 1989 | Substantially Equivalent | Medsurg Industries, Inc. |
| K885149 | NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE | Jan 26, 1989 | Substantially Equivalent | Hart Enterprises, Inc. |
| K882013 | SOFT TISSUE BIOPSY DEVICE | Jun 15, 1988 | Substantially Equivalent | Ocean Medical Products, Ltd. |
| K874585 | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE | Dec 02, 1987 | Substantially Equivalent | Angiomed U.S., Inc. |
| K872597 | FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE | Jul 28, 1987 | Substantially Equivalent | Dianon Systems, Inc. |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Sep 12, 1985 | Substantially Equivalent | Argon Medical Corp. |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | Mar 23, 1982 | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. |
FEI Numbers
This FDA classification entry is associated with 44 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 44 registration numbers. Click on an entry to view related FDA registrations.