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FDA Approved
510(k) Approved
Devices
|
Description |
FDA Number |
Approval Date |
|
Arthogram Tray |
K950683 |
May, 1995 |
|
Extension Lines |
K830420 |
June, 1994/April,1991 |
|
Slide Valve Manifold |
K913094 |
January, 1993 |
|
Digital Inflation Syringe |
K904954 |
November, 1992 |
|
Analog Inflation Syringe |
K904508 |
April, 1992 |
|
Radiopaque Ruler |
K902606 |
September, 1990 |
|
Procedure Ready Trays |
K884577A-C |
August, 1989 |
|
Angiography Drapes |
K890471 |
February,1989 |
|
Control Syringes |
K884497 |
December, 1988 |
|
Fluoro Covers |
K873985 |
January, 1988 |
|
Guidewire Bowl |
K873942 |
December, 1987 |
|
Three-Ring Attachment for Syringe |
K864555 |
December, 1986 |
|
|
K873709 |
December, 1987 |
|
Blood Containment Pack |
K872448 |
November, 1987 |
|
Percutaneous Puncture Needle |
K854941 |
December, 1986/Sept. 1982 |
|
Amniocentesis Tray |
K850632 |
May, 1985 |
|
Opthalmology Pack |
K850050 |
April, 1985 |
|
Drape Pack |
K844465 |
December, 1984 |
|
Suture Pack/Tray |
K842149 |
July, 1984 |
|
Angiography Tray |
K841468 |
June,1984 |
|
Myelogram Tray |
K841217 |
April, 1984 |
|
Cardiac Catheterization Tray |
K840671 |
March, 1984 |
|
Percutaneous Catheter Introducer |
KitK840017 |
February, 1984 |
|
Digital Subtraction Kit |
K830637 |
March, 1983 |
|
Piston Syringe |
K951918 |
March, 1996 |
|
Needles |
K822596 |
September, 1982 |
|
Dilation Catheter |
K833742 |
October, 1983 |
|
Cardiovascular Catheter |
K822594 |
September, 1982 |
|
Monitoring Catheter |
K823253 |
December, 1982 |
|
Pigtail Catheter |
K822598 |
September, 1982 |
|
Monitoring Line 6" |
K942482 |
April, 1994 |
|
Monitoring Line 10" |
K910378 |
January, 1991 |
|
Clear Vinyl Connectors |
K823340A |
December, 1982 |
|
Tuoy-Borst Adapter |
K823192 |
December, 1982 |
|
Guidewire |
K822597 |
September, 1982 |
|
Osciflator Inflation Syringe |
K952566 |
|
A 510(k) is a filing with the Food
and Drug Administration (FDA), for approval of medical devices
manufactured and sold in the United States. Medical Techniques is
registered with the FDA and is ISO 13485:96 certified. The Company has
been audited and found to be in compliance with the rules and
regulations of the FDA and the International Standards for medical
devices.
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