Cleared Traditional

K211741 - Pre-Formed Extra Support Guidewire

K211741 is the FDA 510(k) clearance for Pre-Formed Extra Support Guidewire by Lake Region Medical. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K211741 · Lake Region Medical · Cardiovascular device
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Nov 2021
Decision
168d
Days
Class 2
Risk

K211741 is an FDA 510(k) clearance for the Pre-Formed Extra Support Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Medical (Chaska, US). The FDA issued a Cleared decision on November 22, 2021 after a review of 168 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 Medical devices

Submission Details

510(k) Number K211741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2021
Decision Date November 22, 2021
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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