Cleared Traditional

MULTIPRO CATHETER (K841797) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 316
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K841797.
TRIPLE LUMEN RIGHT ATRIAL CATHETER
K852815 · Quinton, Inc. · Aug 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · Quinton, Inc. · Aug 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984
ULTRA LIGHT RAAF CATHETER
K832784 · Quinton, Inc. · Oct 1983