Cleared Traditional

WIRE, GUIDE, CATHETER (K850829) - FDA 510(k) Clearance

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

K850829 · Lake Region Mfg., Inc. · Cardiovascular device
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Jun 1985
Decision
121d
Days
Class 2
Risk

K850829 is an FDA 510(k) clearance for the WIRE, GUIDE, CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 121 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 Lake Region Mfg., Inc. devices

Submission Details

510(k) Number K850829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date June 26, 1985
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 317
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K850829.
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
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
MAHURKAR DUAL LIMEN FEMORAL CATHETER
K834109 · Quinton, Inc. · Feb 1984