Cleared Special

SUPER SHEATH XL INTRODUCER SHEATH (K060190) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060190 · Togo Medikit Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
70d
Days
Class 2
Risk

K060190 is an FDA 510(k) clearance for the SUPER SHEATH XL INTRODUCER SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Plymouth, US). The FDA issued a Cleared decision on April 4, 2006 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Togo Medikit Co., Ltd. devices

Submission Details

510(k) Number K060190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2006
Decision Date April 04, 2006
Days to Decision 70 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 279
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K060190.
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH
K062446 · Terumo Medical Corp. · Oct 2006
MODIFICATION TO GLIDESHEATH
K062858 · Terumo Medical Corp. · Oct 2006
CAROTID ACCESS KIT
K060666 · Terumo Medical Corp. · Jun 2006
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004