Cleared Traditional

K841797 - MULTIPRO CATHETER

K841797 is an FDA 510(k) clearance for MULTIPRO CATHETER, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K841797 · Shiley, Inc. · Cardiovascular device
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Aug 1984
Decision
109d
Days
Class 2
Risk

K841797 is an FDA 510(k) clearance for the MULTIPRO CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 109 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K841797

510(k) Number K841797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date August 10, 1984
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
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 K841797.
CORONARY INFUSION CATHETER W/SIDEHOLES
K850353 · Advanced Cardiovascular Systems, Inc. · Apr 1985
ARROW-JOHANS ECG ADAPTOR
K843263 · Arrow Intl., Inc. · Sep 1984
CARDIAC SUPPLY TRAY
K842645 · Deroyal Industries, Inc. · Aug 1984
AXIOM FEMORAL VENUS CATHETER
K842084 · Axiom Medical, Inc. · Aug 1984
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · Critikon Company, LLC · Jul 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · Norton Performance Plastics Corp. · Jul 1984