Cleared Traditional

K003551 - VENOUS HARDSHELL CARDIOTOMY RESEVOIR

K003551 is the FDA 510(k) clearance for VENOUS HARDSHELL CARDIOTOMY RESEVOIR by Jostra AG. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K003551 · Jostra AG · Cardiovascular device
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Jul 2001
Decision
236d
Days
Class 2
Risk

K003551 is an FDA 510(k) clearance for the VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Jostra AG (Irvine, US). The FDA issued a Cleared decision on July 11, 2001 after a review of 236 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.

View all Jostra AG devices

Submission Details

510(k) Number K003551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date July 11, 2001
Days to Decision 236 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
111d slower than avg
Panel avg: 125d · This submission: 236d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 127
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K003551.
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · Gish Biomedical, Inc. · May 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · Gish Biomedical, Inc. · Mar 2003
CAPIOX RX HARDSHELL RESERVOIR
K013526 · Terumo Cardiovascular Systems Corp. · Nov 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular · Jul 2001
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp. · Aug 2000
COBE HVR 2200 HARDSHELL VENOUS RESERVOIR, FILTERED
K994389 · Cobe Cardiovascular, Inc. · Mar 2000