Quality & Regulatory Documentation

Description FDA Number Approval Date
Arthrogram 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, 1898
Control Syringes K884497 December 1988
Fluoro Covers K873985 January, 1988
Guidewire Bowl K873942 December, 1987
Three-Ring Attachment for Syringe K864555 / K873709 December 1986 / December 1987
Blood Containment Pack K872448 November 1987
Percutaneous Puncture Needle K854941 December, 1986 / September 1982
Amniocentesis Tray K850632 May, 1985
Opthalmology Pack K850050 April, 1985
Drape Pack K844465 December, 1985
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 Kit K840017 February, 1984
Digital Subtraction Kit K830637 February, 1984
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 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.

Medical Techniques, Inc.   |   890 West Robinson Drive, Suite A   |   North Salt Lake, Utah 84054
ph: 385-535-6654   |   fax: 801-936-4601   |   e-mail: Michael@medtechusa1.com