ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE - Hti Floppy

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K954604 ↗

FDA Product Code

MCW

Models / Variants

Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line

Hti Floppy

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Rotablator Rotational Angioplasty

  Class II

  FDA 510(k) K953997 Active Cleared 22 Dec 1995

• Heart Technology Rotablator Wireclip

  Class II

  FDA 510(k) K913450 Active Cleared 6 Sep 1991

• Rotablator

  Class II

  FDA 510(k) K901206 Active Cleared 14 Sep 1990

• Heart Technology Wireclip

  Class II

  FDA 510(k) K914581 Active Cleared 6 Jan 1992

• Rotablator System's Guide Wire Line: Support Rotawire Rail Rota Wire

  Class II

  FDA 510(k) K960379 Active Cleared 25 Apr 1996

• Rotablator, Modification

  Class II

  FDA 510(k) K933238 Active Cleared 24 Aug 1993

• Is the Rotablator Rotational Atherectomy System designed for use in coronary arteries, or is it specifically for peripheral vessels?

  The Rotablator Rotational Atherectomy System is designed specifically for peripheral atherectomy, meaning it is intended for use in peripheral blood vessels, not coronary arteries. It uses a high-speed rotating burr to mechanically ablate calcified plaque in peripheral arteries to restore vessel lumen patency during percutaneous interventions.

• How is the Rotablator System’s Guide Wire Line (HTI Floppy) supplied, and is it reusable or single-use?

  The Rotablator System’s Guide Wire Line (HTI Floppy) is supplied as a reusable component of the overall Rotablator Rotational Atherectomy System. This means it is intended to be used multiple times after proper cleaning and sterilization, rather than being discarded after a single procedure.

• What types of sterility precautions should be taken when handling the Rotablator System?

  The Rotablator System requires sterile handling, as indicated in its design and regulatory classification. While the reusable components like the guide wire line are not sterile out-of-the-box, they must be cleaned and sterilized before reuse. The burrs and other disposable components must be handled in a sterile manner to maintain clinical standards during procedures.

• What is the regulatory pathway for the Rotablator Rotational Atherectomy System, and what does this mean for clinicians?

  The Rotablator System was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process with a decision code of ‘Substantially Equivalent’ (SESE). This means it was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for peripheral atherectomy catheters. Clinicians can rely on this clearance as part of the device’s regulatory approval.