Cleared Traditional

K852388 - MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT

K852388 is the FDA 510(k) clearance for MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT by Quinton, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K852388 · Quinton, Inc. · Cardiovascular device
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Aug 1985
Decision
73d
Days
Class 2
Risk

K852388 is an FDA 510(k) clearance for the MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Quinton, Inc. devices

Submission Details

510(k) Number K852388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received June 10, 1985
Decision Date August 22, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 592
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K852388.
AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER
K852491 · American Pharmaseal Div. Ahsc · Sep 1985
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
K852914 · Norton Performance Plastics Corp. · Sep 1985
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · Quinton, Inc. · Aug 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
WIRE, GUIDE, CATHETER
K850829 · Lake Region Mfg., Inc. · Jun 1985
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · Advanced Cardiovascular Systems, Inc. · Apr 1985