Cleared Traditional

K041453 - SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 (FDA 510(k) Clearance)

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

K041453 · Smith & Nephew, Inc. · Cardiovascular device
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Jul 2004
Decision
51d
Days
Class 2
Risk

K041453 is an FDA 510(k) clearance for the SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023. Classified as Stripper, Vein, External (product code DWQ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K041453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2004
Decision Date July 22, 2004
Days to Decision 51 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
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWQ Stripper, Vein, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
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.