Cleared Traditional

K942457 - GRAFT THROMBECTOMY INSTRUMENTS

K942457 is an FDA 510(k) clearance for GRAFT THROMBECTOMY INSTRUMENTS, manufactured by Intramed Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K942457 · Intramed Laboratories, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
259d
Days
Class 2
Risk

K942457 is an FDA 510(k) clearance for the GRAFT THROMBECTOMY INSTRUMENTS. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Intramed Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 259 days - an extended review 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: 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 Intramed Laboratories, Inc. devices

FDA 510(k) Submission Details - K942457

510(k) Number K942457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1994
Decision Date February 07, 1995
Days to Decision 259 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K942457.
THROMBOLYTIC BRUSH CATHETER
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ARROW-TREROTOLA PTD CATHETER
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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