Cleared Traditional

K924712 - ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

K924712 is an FDA 510(k) clearance for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM, manufactured by Hearing Tech, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K924712 · Hearing Tech, Inc. · Cardiovascular device
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Dec 1992
Decision
81d
Days
Class 2
Risk

K924712 is an FDA 510(k) clearance for the ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Hearing Tech, Inc. (Bellevue, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 81 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hearing Tech, Inc. devices

FDA 510(k) Submission Details - K924712

510(k) Number K924712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date December 08, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
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 55
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K924712.
THROMBOLYTIC BRUSH CATHETER
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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
TRAC-WRIGHT TRAC 10 CATHETER
K915238 · Dow Corning Wright · Feb 1992
THERATEK GROUP EXCHANGE CATHETER
K904680 · Dow Corning Wright · Dec 1990