ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE - Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line
by Heart Technology Mfg., Inc.
510(k) K954604
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954604 | Date18 Jan 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MCW
- Models / Variants
- Rotablator Rotational Angioplasty System Rotablator System's Guide Wire Line
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Rotablator Rotational Atherectomy System is a catheter-based device designed for peripheral atherectomy, using a high-speed rotating burr to mechanically ablate calcified or hardened plaque within blood vessels. It falls under the category of peripheral atherectomy catheters and is intended for use in percutaneous interventions to restore vessel lumen patency in calcified lesions.
The system is supplied as a reusable medical device, incorporating a guide wire line (HTI Floppy) for navigation and procedural support. It is regulated under FDA 510(k) clearance (K954604) and classified as a Class II device (regulation number 870.4875). The device requires sterile handling and is intended for use in controlled clinical settings, with specific burr sizes and guide catheter compatibility as outlined in procedural guidelines.
Other devices from Heart Technology, Inc.
Questions
AI-generated answers, 19 Sep 2026
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.