Cleared Traditional

K980723 - 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) (FDA 510(k) Clearance)

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

K980723 · Vascutech, Inc. · Cardiovascular device
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Feb 1999
Decision
353d
Days
Class 2
Risk

K980723 is an FDA 510(k) clearance for the 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT). Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Vascutech, Inc. (Burlington, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Vascutech, Inc. devices

Submission Details

510(k) Number K980723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date February 12, 1999
Days to Decision 353 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 125d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MGZ Valvulotome
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.