Cleared Special

K992910 - AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) (FDA 510(k) Clearance)

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

K992910 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
16d
Days
Class 2
Risk

K992910 is an FDA 510(k) clearance for the AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE .... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on September 15, 1999 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K992910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1999
Decision Date September 15, 1999
Days to Decision 16 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 253
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