Cleared Traditional

K003889 - ANCURE SHEATH MODEL # 40315, 40320, 40325 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003889 · Guidant Cardiac and Vascular Surgery · Cardiovascular device
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Jan 2002
Decision
402d
Days
Class 2
Risk

K003889 is an FDA 510(k) clearance for the ANCURE SHEATH MODEL # 40315, 40320, 40325. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Guidant Cardiac and Vascular Surgery (Menlo Park, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 402 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 Guidant Cardiac and Vascular Surgery devices

Submission Details

510(k) Number K003889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2000
Decision Date January 24, 2002
Days to Decision 402 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
277d slower than avg
Panel avg: 125d · This submission: 402d
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 700
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