Cleared Traditional

K935170 - CARDIOVASCULAR AND VASCULAR GUIDEWIRE M...

K935170 is an FDA 510(k) clearance for CARDIOVASCULAR AND VASCULAR GUIDEWIRE M..., 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 155-day FDA review.

K935170 · Lake Region Mfg., Inc. · Cardiovascular device
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Mar 1994
Decision
155d
Days
Class 2
Risk

K935170 is an FDA 510(k) clearance for the CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS. 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 March 31, 1994 after a review of 155 days - an extended review cycle.

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 - K935170

510(k) Number K935170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date March 31, 1994
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 K935170.
CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES
K941485 · Cardio Metrics, Inc. · May 1994
SCIMED 0.014 PTCA GUIDE WIRE WITH ICE HYDROPHILIC COATING
K941895 · Scimed Life Systems, Inc. · May 1994
ONTRAC STEERABLE GUIDEWIRE
K941229 · Lake Region Mfg., Inc. · May 1994
TORQUE DEVICE
K936032 · Merit Medical Systems, Inc. · Mar 1994
SCIMED ENTRE PTCA GUIDE WIRE WITH J-TIP
K935905 · Scimed Life Systems, Inc. · Mar 1994
ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE
K930982 · Cordis Corp. · Feb 1994