Cleared Traditional

K911184 - SCANLAN/TAHERI VALVULOTOME

K911184 is the FDA 510(k) clearance for SCANLAN/TAHERI VALVULOTOME by Scanlan Intl., Inc.. It is a Class 2 Cardiovascular device (product code MGZ) cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K911184 · Scanlan Intl., Inc. · Cardiovascular device
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Feb 1992
Decision
337d
Days
Class 2
Risk

K911184 is an FDA 510(k) clearance for the SCANLAN/TAHERI VALVULOTOME. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 337 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K911184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date February 18, 1992
Days to Decision 337 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 125d · This submission: 337d
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.

Regulatory Peers - MGZ Valvulotome

All 13
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K911184.
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