Cleared Traditional

K071196 - DISPOSABLE HIGH PRESSURE INJECTION LINE...

K071196 is an FDA 510(k) clearance for DISPOSABLE HIGH PRESSURE INJECTION LINE..., manufactured by Coeur, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K071196 · Coeur, Inc. · Cardiovascular device
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Sep 2007
Decision
129d
Days
Class 2
Risk

K071196 is an FDA 510(k) clearance for the DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on September 6, 2007 after a review of 129 days - within the typical 510(k) review window.

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 Coeur, Inc. devices

FDA 510(k) Submission Details - K071196

510(k) Number K071196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date September 06, 2007
Days to Decision 129 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
4d slower than avg
Panel avg: 125d · This submission: 129d
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 355
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K071196.
GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
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K072796 · Concentric Medical, Inc. · Dec 2007
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K072526 · Micrus Endovascular Corporation · Oct 2007
MICRUS COURIER ENZO MICROCATHETER 0.017
K070456 · Micrus Endovascular Corporation · May 2007
DYE MANAGEMENT SYSTEM
K063784 · Icu Medical, Inc. · Apr 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · Vascular Solutions, Inc. · Jan 2007