Cleared Special

CLEARWAY RX NB CATHETER (K113112) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113112 · Atrium Medical Corp. · Cardiovascular device
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Nov 2011
Decision
28d
Days
Class 2
Risk

K113112 is an FDA 510(k) clearance for the CLEARWAY RX NB CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on November 17, 2011 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

Submission Details

510(k) Number K113112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date November 17, 2011
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 317
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K113112.
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K120229 · Codman & Shurtleff, Inc. · Feb 2012
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K112917 · Medtronic, Inc. · Oct 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · Codman & Shurtleff, Inc. · Oct 2011
GLIDECROSS SUPPORT CATHETER
K111556 · Terumo Medical Corp. · Jul 2011