Cleared Special

K001138 - AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 (FDA 510(k) Clearance)

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

K001138 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
17d
Days
Class 2
Risk

K001138 is an FDA 510(k) clearance for the AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODE.... Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 K001138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date April 27, 2000
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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.