Cleared Traditional

K001734 - FOGARTY VALVULOTOME

K001734 is an FDA 510(k) clearance for FOGARTY VALVULOTOME, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code MGZ cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K001734 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
292d
Days
Class 2
Risk

K001734 is an FDA 510(k) clearance for the FOGARTY VALVULOTOME, MODEL 700091. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on March 26, 2001 after a review of 292 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K001734

510(k) Number K001734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2000
Decision Date March 26, 2001
Days to Decision 292 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 125d · This submission: 292d
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 12
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K001734.
LEMILLS VALVULOTOME
K132047 · LeMaitre Vascular, Inc. · Nov 2013
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
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