Cleared Traditional

K954604 - ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE

Also marketed or referenced as:
HTI FLOPPY

K954604 is an FDA 510(k) clearance for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTE..., manufactured by Heart Technology Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K954604 · Heart Technology Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
106d
Days
Class 2
Risk

K954604 is an FDA 510(k) clearance for the ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Heart Technology Mfg., Inc. (Redmond, US). The FDA issued a Cleared decision on January 18, 1996 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K954604

510(k) Number K954604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date January 18, 1996
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K954604.
POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
K960970 · Possis Medical, Inc. · Dec 1996
THE AMPLATZ THROMBECTOMY DEVICE
K954205 · Microvena Corp. · Aug 1996
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
K960379 · Heart Technology Mfg., Inc. · Apr 1996
ROTABLATOR ROTATIONAL ANGIOPLASTY
K953997 · Heart Technology Mfg., Inc. · Dec 1995
GRAFT THROMBECTOMY INSTRUMENTS
K942457 · Intramed Laboratories, Inc. · Feb 1995
MICROTRACK
K935929 · Devices For Vascular Intervention, Inc. · Mar 1994
K954604 · ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
Download PDF FDA Summary Heart Technology Mfg.…