Cleared Traditional

K850337 - CARDIAC CATHETERIZATION PACK

K850337 is the FDA 510(k) clearance for CARDIAC CATHETERIZATION PACK by Marwood Medical, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K850337 · Marwood Medical, Inc. · Cardiovascular device
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Feb 1985
Decision
28d
Days
Class 2
Risk

K850337 is an FDA 510(k) clearance for the CARDIAC CATHETERIZATION PACK. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Marwood Medical, Inc. (Greensboro, US). The FDA issued a Cleared decision on February 25, 1985 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Marwood Medical, Inc. devices

Submission Details

510(k) Number K850337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1985
Decision Date February 25, 1985
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 44
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K850337.
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MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
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K842113 · Mallinckrodt Critical Care · Jul 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · Quinton, Inc. · Dec 1983