Cleared Traditional

K061832 - JOSTRA HLM TUBING SETS WITH SAFELINE CO...

K061832 is the FDA 510(k) clearance for JOSTRA HLM TUBING SETS WITH SAFELINE CO... by Maquet Cardiopulmonary, AG. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K061832 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Aug 2006
Decision
43d
Days
Class 2
Risk

K061832 is an FDA 510(k) clearance for the JOSTRA HLM TUBING SETS WITH SAFELINE COATING. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Warrington, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K061832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2006
Decision Date August 11, 2006
Days to Decision 43 days
Submission Type Traditional
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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 202
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K061832.
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
K072172 · Maquet Cardiopulmonary, AG · Aug 2007
TENDERFLOW PERIATRIC ARTERIAL CANNULA
K063618 · Terumo Cardiovascular Systems Corp. · Mar 2007
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA
K062597 · Terumo Cardiovascular Systems Corp. · Nov 2006
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · Edwards Lifesciences, LLC · Jul 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE
K033464 · Edwards Lifesciences, LLC · Jun 2004
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · Medtronic Vascular · Jan 2004