BALT Guiding Catheter

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

510(k) Number

K925632 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

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 BALT Guiding Catheter used for in cardiac procedures?

  The BALT Guiding Catheter is designed for intracardiac pressure monitoring, blood sampling, and the introduction of substances into the heart and blood vessels. This allows clinicians to obtain real-time diagnostic information during catheter-based interventions, improving procedural guidance and safety in interventional cardiology.

• Is the BALT Guiding Catheter intended for single-use or reuse?

  The BALT Guiding Catheter is supplied as a single-use device. This design ensures sterility and safety for each patient procedure, reducing the risk of cross-contamination and maintaining device integrity per manufacturer guidelines.

• Where should the BALT Guiding Catheter be stored to maintain its integrity?

  The BALT Guiding Catheter must be stored according to the manufacturer’s instructions to preserve its functionality and sterility. Proper storage conditions prevent damage and contamination, ensuring the device remains effective for its intended use in sterile clinical settings like cardiac catheterization labs.

• What regulatory clearance does the BALT Guiding Catheter hold?

  The BALT Guiding Catheter holds FDA 510(k) clearance under the reference number K925632. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory standards for cardiovascular diagnostic catheters.

• Can the BALT Guiding Catheter be used in MRI environments?

  The regulatory data for the BALT Guiding Catheter does not specify MRI safety information. Clinicians should verify compatibility with MRI equipment and protocols before use, as the device’s materials or construction may not be explicitly rated for MRI environments.