Cleared Traditional

K960379 - ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE

K960379 is an FDA 510(k) clearance for ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SU..., 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 90-day FDA review.

K960379 · Heart Technology Mfg., Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
90d
Days
Class 2
Risk

K960379 is an FDA 510(k) clearance for the ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE. 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 April 25, 1996 after a review of 90 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.

View all Heart Technology Mfg., Inc. devices

FDA 510(k) Submission Details - K960379

510(k) Number K960379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1996
Decision Date April 25, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 119
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K960379.
ARROW-TREROTOLA PTD CATHETER
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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 ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
K954604 · Heart Technology Mfg., Inc. · Jan 1996
TRAC-WRIGHT TRAC 10 CATHETER
K915238 · Dow Corning Wright · Feb 1992
THERATEK GROUP EXCHANGE CATHETER
K904680 · Dow Corning Wright · Dec 1990