Cleared Traditional

K852491 - AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER

K852491 is an FDA 510(k) clearance for AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K852491 · American Pharmaseal Div. Ahsc · Cardiovascular device
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Sep 1985
Decision
105d
Days
Class 2
Risk

K852491 is an FDA 510(k) clearance for the AMERICAN PHARMASEAL TRIPLE LUMEN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Glendale, US). The FDA issued a Cleared decision on September 25, 1985 after a review of 105 days - within the typical 510(k) review window.

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: 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K852491

510(k) Number K852491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date September 25, 1985
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K852491.
INFUSION CATHETER
K853997 · Target Therapeutics · Nov 1985
INFUSION CATHETER W/SIDE HOLES
K854000 · Target Therapeutics · Nov 1985
REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE
K853860 · Quinton, Inc. · Oct 1985
ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION
K852914 · Norton Performance Plastics Corp. · Sep 1985
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · Quinton, Inc. · Aug 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · Quinton, Inc. · Aug 1985