Cleared Traditional

K033328 - NOVOSCI TUBING AND CONNECTORS WITH NOVO...

K033328 is the FDA 510(k) clearance for NOVOSCI TUBING AND CONNECTORS WITH NOVO... by Novosci Corp.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K033328 · Novosci Corp. · Cardiovascular device
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Jan 2004
Decision
92d
Days
Class 2
Risk

K033328 is an FDA 510(k) clearance for the NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Novosci Corp. (The Woodlands, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Novosci Corp. devices

Submission Details

510(k) Number K033328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2003
Decision Date January 16, 2004
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 66
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