Cleared Traditional

K942977 - NOVOSTE PULSE PLUS BLOOD CONTAINMENT DE...

K942977 is the FDA 510(k) clearance for NOVOSTE PULSE PLUS BLOOD CONTAINMENT DE... by Novoste Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 556-day FDA review.

K942977 · Novoste Corp. · Cardiovascular device
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Dec 1995
Decision
556d
Days
Class 2
Risk

K942977 is an FDA 510(k) clearance for the NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Novoste Corp. (Norcross, US). The FDA issued a Cleared decision on December 28, 1995 after a review of 556 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Novoste Corp. devices

Submission Details

510(k) Number K942977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1994
Decision Date December 28, 1995
Days to Decision 556 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
431d slower than avg
Panel avg: 125d · This submission: 556d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 392
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