Sci Med Temperature Monitoring Adaptor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K831260 ↗

FDA Product Code

DTL

Device Class

Class II

Regulation

21 CFR Part 870.4290

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the SCI MED TEMPERATURE MONITORING ADAPTOR used for?

  The SCI MED TEMPERATURE MONITORING ADAPTOR is used as an adaptor, stopcock, manifold, or fitting in cardiopulmonary bypass systems to connect monitoring equipment, based on its classification under regulation number 870.4290 for cardiovascular devices.

• How was the SCI MED TEMPERATURE MONITORING ADAPTOR cleared for market?

  The device received FDA 510(k) clearance (K831260) on June 3, 1983, as substantially equivalent to a predicate device, following a traditional review process by Scimed Life Systems, Inc.

• Who manufactures the SCI MED TEMPERATURE MONITORING ADAPTOR and where is it located?

  Scimed Life Systems, Inc. manufactures the SCI MED TEMPERATURE MONITORING ADAPTOR at their facility located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States.