IVT Guiding Catheter

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

510(k) Number

K911869 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Ivt Peripheral Atherectomy

  Class II

  FDA 510(k) K901767 Active Cleared 28 Jun 1990

• Ivt Introducer Sheath

  Class II

  FDA 510(k) K903463 Active Cleared 3 Jan 1991

• Peripheral Atherectomy System

  Class II

  FDA 510(k) K890515 Active Cleared 23 May 1989

• Aptt by Hemochron(R)

  Class II

  FDA 510(k) K892209 Active Cleared 22 Jun 1989

• Modified Ivt Peripheral Atherectomy System

  Class II

  FDA 510(k) K896403 Active Cleared 6 Mar 1990

• Hemochron(R) Heparin Response Test

  Class II

  FDA 510(k) K904003 Active Cleared 29 Nov 1990

See all devices from Intensive Technology, Inc. →

• What is the IVT Guiding Catheter used for?

  The IVT Guiding Catheter is a medical device used in cardiovascular procedures to guide other catheters or devices through blood vessels. It provides access and support during interventions in the cardiovascular system.

• How is the IVT Guiding Catheter supplied?

  The IVT Guiding Catheter is supplied by Intensive Technology, Inc. and is available in various sizes as indicated by the model numbers. It is intended for single-use only.

• What is the regulatory status of the IVT Guiding Catheter?

  The IVT Guiding Catheter has received FDA 510(k) clearance with product code DQY. It was determined to be substantially equivalent to other devices in this category.

• How should the IVT Guiding Catheter be stored?

  The IVT Guiding Catheter should be stored according to the manufacturer's instructions. As a single-use device, it should be properly stored until use and then discarded after a single procedure.