FDA 510(k) Applications for Medical Device Product Code "DWO"
(Needle, Biopsy, Cardiovascular)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K874585 |
ANGIOMED U.S., INC. |
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE |
12/02/1987 |
K853312 |
ARGON MEDICAL CORP. |
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES |
09/12/1985 |
K820269 |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
RNG SERIES ULTRASOUND NEEDLE/CATH. GDS |
03/23/1982 |
K872597 |
DIANON SYSTEMS, INC. |
FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE |
07/28/1987 |
K913815 |
HART ENTERPRISES, INC. |
AUTOMATED BIOPSY DEVICE, MODIFICATION |
10/30/1991 |
K885149 |
HART ENTERPRISES, INC. |
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE |
01/26/1989 |
K890925 |
MANAN MEDICAL PRODUCTS, INC. |
MANAN BONE MARROW BIOPSY NEEDLE |
04/11/1989 |
K921418 |
MEDICAL DEVICE TECHNOLOGIES, INC. |
ULTRA-CORE BIOPSY NEEDLES |
06/19/1992 |
K885145 |
MEDSURG INDUSTRIES, INC. |
MEDSURG GREENE NEEDLE |
03/14/1989 |
K882013 |
OCEAN MEDICAL PRODUCTS, LTD. |
SOFT TISSUE BIOPSY DEVICE |
06/15/1988 |
K933364 |
VLV ASSOCIATES, INC. |
PROMED BIOPSY NEEDLE |
02/15/1994 |
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