Cleared Traditional

K871882 - LAKE REGION VARIABLE STIFFNESS GUIDEWIR...

K871882 is an FDA 510(k) clearance for LAKE REGION VARIABLE STIFFNESS GUIDEWIR..., 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 127-day FDA review.

K871882 · Lake Region Mfg., Inc. · Cardiovascular device
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Sep 1987
Decision
127d
Days
Class 2
Risk

K871882 is an FDA 510(k) clearance for the LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW). 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 September 15, 1987 after a review of 127 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 - K871882

510(k) Number K871882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1987
Decision Date September 15, 1987
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K871882.
TELEFLEX STEERABLE GUIDEWIRE
K871850 · Teleflexmedical, Inc. · Jan 1988
STUBBIE STEERABLE GUIDEWIRE
K873543 · Target Therapeutics · Dec 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · Olympus Corp. · Nov 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · Advanced Cardiovascular Systems, Inc. · Aug 1987
MINISTIK MINI PUNCTURE SET CATALOG CODE #57505
K871137 · Dlp, Inc. · Jul 1987
GUIDE WIRE
K870664 · Datascope Corp. · Mar 1987