Cleared Traditional

K964017 - AFFINITY BLOOD PUMP SYSTEM

K964017 is an FDA 510(k) clearance for AFFINITY BLOOD PUMP SYSTEM, manufactured by Avecor Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K964017 · Avecor Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
302d
Days
Class 2
Risk

K964017 is an FDA 510(k) clearance for the AFFINITY BLOOD PUMP SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Avecor Cardiovascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 5, 1997 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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. Elevated predicate reliance profile. 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 Avecor Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K964017

510(k) Number K964017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date August 05, 1997
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 38
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K964017.
STOCKERT S5 SYSTEM
K060053 · Sorin Group Deutschland GmbH · Jun 2006
ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
K022947 · Terumo Cardiovascular Systems Corp. · Mar 2003
STOCKERT COMPACT SYSTEM
K982014 · Stoeckert Instrumente · Sep 1998
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
K943803 · Janus Biomedical, Inc. · Jan 1996
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
K950990 · Stoeckert Instrumente · Jan 1996
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · 3M Health Care, Sarns · Jul 1992