Cleared Traditional

K120707 - SWITCH-IT CATHETER

K120707 is an FDA 510(k) clearance for SWITCH-IT CATHETER, manufactured by Vascular Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K120707 · Vascular Solutions, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
68d
Days
Class 2
Risk

K120707 is an FDA 510(k) clearance for the SWITCH-IT 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 May 15, 2012 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascular Solutions, Inc. devices

FDA 510(k) Submission Details - K120707

510(k) Number K120707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2012
Decision Date May 15, 2012
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 673
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K120707.
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M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
K112100 · Vascular Solutions, Inc. · Mar 2012
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K112404 · Concentric Medical, Inc. · Mar 2012