Cleared Special

K061527 - CARD 43 CARDIOTOMY RESERVOIR WITH PHOSP...

K061527 is the FDA 510(k) clearance for CARD 43 CARDIOTOMY RESERVOIR WITH PHOSP... by Sorin Group Italia S.R.L.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Special 510(k) pathway after a 25-day FDA review.

K061527 · Sorin Group Italia S.R.L. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2006
Decision
25d
Days
Class 2
Risk

K061527 is an FDA 510(k) clearance for the CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on June 27, 2006 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Sorin Group Italia S.R.L. devices

Submission Details

510(k) Number K061527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date June 27, 2006
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K061527.
JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
K070605 · Maquet Cardiopulmonary, AG · Jan 2008
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K070839 · Terumo Cardiovascular Systems Corp. · Apr 2007
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743 · Maquet Cardiopulmonary, AG · Jul 2006
GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING
K051606 · Gish Biomedical, Inc. · Aug 2005
V-BAG WITH GBS COATING
K050195 · Gish Biomedical, Inc. · Mar 2005
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
K050111 · Cobe Cardiovascular, Inc. · Mar 2005