Cleared Traditional

K945065 - DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063

K945065 is an FDA 510(k) clearance for DIDECO FLEXIBLE RESERVOIR -- PRODUCT DE..., manufactured by Sorin Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K945065 · Sorin Biomedical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
217d
Days
Class 2
Risk

K945065 is an FDA 510(k) clearance for the DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 19, 1995 after a review of 217 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 - K945065

510(k) Number K945065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date May 19, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K945065.
MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
K961836 · Medtronic Vascular · Nov 1996
BIOCOR 200 HARDSHELL VENOUS RESERVIOR
K953821 · Minntech Corp. · Mar 1996
SOFT VENOUS RESERVOIR
K955046 · Gish Biomedical, Inc. · Jan 1996
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215 · Sorin Biomedical, Inc. · May 1995
AFFINITY CVR
K936003 · Avecor Cardiovascular, Inc. · Jun 1994
AFFINITY VENOUS RESERVIOR BAG
K935717 · Avecor Cardiovascular, Inc. · May 1994
K945065 · DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
Download PDF Sorin Biomedical, Inc.