ThromCat Thrombectomy Catheter System

• • Terminated Z-1115-2007 FDA Unclassified (pre-2012) ·initiated 21 May 2007

  Defective component (power supply)

• • Terminated Z-0597-2007 FDA Unclassified (pre-2012) ·initiated 7 Feb 2007

  Face seal may wear excessively and cause particulate matter.

510(k) Number

K060016 ↗

FDA Product Code

MCW

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Thromcat Thrombectomy Catheter System

  Class II

  FDA 510(k) K072195 Active Cleared 23 Aug 2007

See all devices from Kensey Nash Corp. →

• What is the primary use of the ThromCat Thrombectomy Catheter System in clinical settings?

  The ThromCat Thrombectomy Catheter System is designed specifically for mechanical removal of thrombus (blood clots) in vascular access pathways. It is intended for use in percutaneous procedures to macerate and remove clots from synthetic hemodialysis grafts or native vessel dialysis fistulae, thereby restoring blood flow in these critical pathways.

• Is the ThromCat Thrombectomy Catheter System intended for single-use or reusable applications?

  The ThromCat Thrombectomy Catheter System is explicitly labeled as a single-use, disposable device. This ensures sterility and safety for one patient per procedure, adhering to standard sterile technique guidelines in clinical settings.

• What size catheter is included in the ThromCat Thrombectomy Catheter System, and how is it supplied?

  The system includes a 5.5 Fr catheter, supplied sterile and ready for immediate use. It is designed for controlled clinical procedures and comes as a complete, disposable package to maintain sterility until deployment.

• How was the ThromCat Thrombectomy Catheter System approved by the FDA, and what regulatory pathway was followed?

  The ThromCat Thrombectomy Catheter System was cleared via the Traditional 510(k) pathway under the FDA’s Class II device regulation (870.4875). It was determined to be *substantially equivalent* to a predicate device, with the review handled by the Cardiovascular (CV) Advisory Committee. The clearance date was April 25, 2006.

• What types of vascular access pathways is the ThromCat system intended to treat?

  The ThromCat Thrombectomy Catheter System is specifically intended for use in synthetic hemodialysis grafts and native vessel dialysis fistulae. It is not designed for general vascular applications but focuses on restoring patency in these high-flow, dialysis-related access sites.