Cleared Traditional

K980723 - 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (...

K980723 is an FDA 510(k) clearance for 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (..., manufactured by Vascutech, Inc.. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 353-day FDA review.

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

FDA 510(k) Submission Details - K980723

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.

MGZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MGZ Valvulotome

All 13
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K980723.
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190 · LeMaitre Vascular, Inc. · Aug 2013
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884 · LeMaitre Vascular, Inc. · Jul 2011
FOGARTY VALVULOTOME, MODEL 700091
K001734 · Edwards Lifesciences, LLC · Mar 2001
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011 · Uresil Corp. · May 1993
OLYMPUS RETRACTABLE VALVULOTOME
K911702 · Olympus Corp. · Dec 1991
MEHIGAN-PILLING PHLEBETOME TM
K911100 · Pilling Co. · Jun 1991