Cleared Traditional

K112100 - M2 NAVIGATION CATHETER AND GUIDELINER N...

K112100 is the FDA 510(k) clearance for M2 NAVIGATION CATHETER AND GUIDELINER N... by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K112100 · Vascular Solutions, Inc. · Cardiovascular device
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Mar 2012
Decision
242d
Days
Class 2
Risk

K112100 is an FDA 510(k) clearance for the M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 20, 2012 after a review of 242 days - an extended review cycle.

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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K112100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date March 20, 2012
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 505
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K112100.
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K122394 · Boston Scientific Corp · Aug 2012
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SWITCH-IT CATHETER
K120707 · Vascular Solutions, Inc. · May 2012
ENVOY DISTAL ACCESS GUIDING CATHETER
K120229 · Codman & Shurtleff, Inc. · Feb 2012
VALET MICRO CATHETER
K112035 · Volcano Corporation · Jan 2012
GUIDELINER V2 CATHETER
K112082 · Vascular Solutions, Inc. · Dec 2011