Cleared Traditional

K120964 - UPSTREAM GR CATHETER

K120964 is an FDA 510(k) clearance for UPSTREAM GR 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 56-day FDA review.

K120964 · Upstream Peripheral Technologies · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
56d
Days
Class 2
Risk

K120964 is an FDA 510(k) clearance for the UPSTREAM GR 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 May 25, 2012 after a review of 56 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 Upstream Peripheral Technologies devices

FDA 510(k) Submission Details - K120964

510(k) Number K120964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date May 25, 2012
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K120964.
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SWITCH-IT CATHETER
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EXCELSIOR XT-27 MICROCATHETER
K113778 · Stryker Neurovascular · Apr 2012
M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER
K112100 · Vascular Solutions, Inc. · Mar 2012