Cleared Traditional

K020784 - JOSTRA SINGLE STAGE VENOUS RETURN CATHE...

K020784 is the FDA 510(k) clearance for JOSTRA SINGLE STAGE VENOUS RETURN CATHE... by Jostra AG. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K020784 · Jostra AG · Cardiovascular device
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Jan 2003
Decision
304d
Days
Class 2
Risk

K020784 is an FDA 510(k) clearance for the JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Jostra AG (Oxford, US). The FDA issued a Cleared decision on January 9, 2003 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K020784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2002
Decision Date January 09, 2003
Days to Decision 304 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
179d slower than avg
Panel avg: 125d · This submission: 304d
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 230
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K020784.
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K030231 · Sorin Group Italia S.R.L. · Apr 2003
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K023880 · Ethicon, Inc. · Dec 2002
CIRCUIT TUBINGS WITH X-COATING
K023056 · Terumo Cardiovascular Systems Corp. · Nov 2002