Cleared Traditional

K935717 - AFFINITY VENOUS RESERVIOR BAG

K935717 is an FDA 510(k) clearance for AFFINITY VENOUS RESERVIOR BAG, manufactured by Avecor Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K935717 · Avecor Cardiovascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
161d
Days
Class 2
Risk

K935717 is an FDA 510(k) clearance for the AFFINITY VENOUS RESERVIOR BAG. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Avecor Cardiovascular, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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.

FDA 510(k) Submission Details - K935717

510(k) Number K935717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date May 10, 1994
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 164
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K935717.
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K945065 · Sorin Biomedical, Inc. · May 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215 · Sorin Biomedical, Inc. · May 1995
AFFINITY CVR
K936003 · Avecor Cardiovascular, Inc. · Jun 1994
SORIN BLOOD CARDIOPLEGIA SYSTEM
K934763 · Sorin Biomedical, Inc. · Apr 1994
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
K934847 · Sorin Biomedical, Inc. · Apr 1994
SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMS
K936183 · Sorin Biomedical, Inc. · Mar 1994
K935717 · AFFINITY VENOUS RESERVIOR BAG
Download PDF FDA Summary Avecor Cardiovascular…