Stealth Dilation Catheter System (Modified)

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

510(k) Number

K915895 ↗

FDA Product Code

LIT

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Diagnostic Intravascular Catheter

  Class II

  FDA 510(k) K925813 Active Cleared 23 Mar 1994

• Angiographic Catheter

  Class II

  FDA 510(k) K926243 Active Cleared 16 Aug 1993

• Retriever II

  Class II

  FDA 510(k) K964210 Active Cleared 31 Oct 1997

• Infusion Catheter W/Side Holes

  Class II

  FDA 510(k) K854000 Active Cleared 5 Nov 1985

• Guide Wire Introducer

  Class II

  FDA 510(k) K873972 Active Cleared 1 Apr 1988

• Turbo Tracker

  Class II

  FDA 510(k) K960806 Active Cleared 2 May 1996

See all devices from Target Therapeutics →

• What is the Stealth Dilation Catheter System (Modified) used for?

  The Stealth Dilation Catheter System (Modified) is specifically designed for angioplasty procedures in peripheral vessels within the cardiovascular system. It facilitates transluminal dilation to treat narrowed or blocked arteries.

• How is the Stealth Dilation Catheter System supplied?

  The device is supplied by Target Therapeutics. It comes in a configuration suitable for peripheral angioplasty procedures, though specific packaging details aren't provided in the available information.

• What regulatory clearance has the Stealth Dilation Catheter System received?

  The Stealth Dilation Catheter System (Modified) received FDA 510(k) clearance with number K915895 on June 4, 1992. It is classified under product code LIT and regulation number 870.1250 as a catheter for peripheral angioplasty.

• Is the Stealth Dilation Catheter System reusable or single-use?

  The available information does not specify whether the Stealth Dilation Catheter System is designed for single-use or multiple reuse. This detail would typically be found in the device's instructions for use, which aren't provided in the current data.