Cleared Traditional

K850829 - WIRE

K850829 is an FDA 510(k) clearance for WIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

FDA 510(k) Submission Details - K850829

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
Combination Product No
PCCP Authorized No
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.

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 620
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
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