Cleared Traditional

K911184 - SCANLAN/TAHERI VALVULOTOME

K911184 is an FDA 510(k) clearance for SCANLAN/TAHERI VALVULOTOME, manufactured by Scanlan Intl., Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K911184

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
Combination Product No
PCCP Authorized No
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.

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 16
Devices cleared under the same product code (MGZ) and FDA review panel - the closest regulatory comparables to K911184.
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723 · Vascutech, Inc. · Feb 1999
FOGARTY VALVULOTOME MODEL 700091
K965137 · Baxter Edwards · Jun 1997
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