Cleared Traditional

K003551 - VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201

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

K003551 · Jostra AG · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K003551

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.

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 149
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K003551.
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · Terumo Corp. · Mar 2003
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · Medtronic Perfusion Systems · May 2002
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
MODEL 4815 ADAPTER
K002496 · Pace Medical · Oct 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp. · Aug 2000