Cleared Traditional

K850828 - WIRE

K850828 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 DQX cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K850828 · Lake Region Mfg., Inc. · Cardiovascular device
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Jun 1985
Decision
121d
Days
Class 2
Risk

K850828 is an FDA 510(k) clearance for the WIRE, GUIDE - MODIFICATION. Classified as Wire, Guide, Catheter (product code DQX), 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 870.1330 - 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 - K850828

510(k) Number K850828 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.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K850828.
TELEFLEX GUIDEWIRE
K850677 · Teleflexmedical, Inc. · Sep 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · Advanced Cardiovascular Systems, Inc. · Jul 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827 · Lake Region Mfg., Inc. · Jun 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · Advanced Cardiovascular Systems, Inc. · Jun 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · Advanced Cardiovascular Systems, Inc. · Jun 1985
BIOPATCH BOVINE PERICARDIAL PATCH
K840756 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1985