Cleared Traditional

K070034 - REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES (FDA 510(k) Clearance)

Class I Cardiovascular device.

K070034 · Ascent Healthcare Solutions · Cardiovascular device
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Aug 2007
Decision
226d
Days
Class 1
Risk

K070034 is an FDA 510(k) clearance for the REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES. Classified as Stabilizer, Heart, Non-compression, Reprocessed (product code NQG), Class I - General Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 226 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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.

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Submission Details

510(k) Number K070034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date August 17, 2007
Days to Decision 226 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
101d slower than avg
Panel avg: 125d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NQG Stabilizer, Heart, Non-compression, Reprocessed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
Definition The Device Is Used To Stabilize, Move, Lift, And Position The Heart During Cardiovascular Surgery. Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.