Cleared Traditional

K112886 - UPSTREAM SUPPORT CATHETER

K112886 is an FDA 510(k) clearance for UPSTREAM SUPPORT CATHETER, manufactured by Upstream Peripheral Technologies. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K112886 · Upstream Peripheral Technologies · Cardiovascular device
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Feb 2012
Decision
146d
Days
Class 2
Risk

K112886 is an FDA 510(k) clearance for the UPSTREAM SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Upstream Peripheral Technologies (Philedelphia, US). The FDA issued a Cleared decision on February 23, 2012 after a review of 146 days - within the typical 510(k) review window.

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 Upstream Peripheral Technologies devices

FDA 510(k) Submission Details - K112886

510(k) Number K112886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date February 23, 2012
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
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 659
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K112886.
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CONCENTRIC BALLOON GUIDE CATHETER
K112404 · Concentric Medical, Inc. · Mar 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
CLEARWAY RX NB CATHETER
K113112 · Atrium Medical Corp. · Nov 2011