Cleared Traditional

MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F) (K952984) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952984 · Map Medical Equipment, Inc. · Cardiovascular device
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Jan 1996
Decision
215d
Days
Class 2
Risk

K952984 is an FDA 510(k) clearance for the MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F). Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Map Medical Equipment, Inc. (North Lawrence, US). The FDA issued a Cleared decision on January 29, 1996 after a review of 215 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Map Medical Equipment, Inc. devices

Submission Details

510(k) Number K952984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1995
Decision Date January 29, 1996
Days to Decision 215 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
90d slower than avg
Panel avg: 125d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 153
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K952984.
4F NYLEX ANGIOGRAPHIC CATHETER
K962759 · Cordis Corp. · Oct 1996
1-4F INFINITI ANGIOGRAPHIC CATHETER
K960975 · Cordis Corp. · Apr 1996
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
K955485 · B.Braun Medical, Inc. · Feb 1996
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
0.035 IN. WISE WIRE
K942927 · Boston Scientific Corp · Jun 1995