Cleared Traditional

K092118 - ANGIOGRAPHIC CATHETER

K092118 is an FDA 510(k) clearance for ANGIOGRAPHIC CATHETER, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K092118 · Oscor, Inc. · Cardiovascular device
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Jan 2010
Decision
183d
Days
Class 2
Risk

K092118 is an FDA 510(k) clearance for the ANGIOGRAPHIC CATHETER, MODEL ANGIOS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on January 13, 2010 after a review of 183 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Oscor, Inc. devices

FDA 510(k) Submission Details - K092118

510(k) Number K092118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date January 13, 2010
Days to Decision 183 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 125d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K092118.
COHEN CROSSOVER CATHETER
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MICRUS MICROCATHETER, MODEL COURIER 270
K092702 · Micrus Endovascular Corporation · Nov 2009
MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
K091961 · Concentric Medical, Inc. · Jul 2009
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00
K083922 · Micrus Endovascular Corporation · May 2009