Cleared Traditional

K141070 - SUPER SHEATH

K141070 is an FDA 510(k) clearance for SUPER SHEATH, manufactured by Togo Medikit Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K141070 · Togo Medikit Co., Ltd. · Cardiovascular device
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Jan 2015
Decision
265d
Days
Class 2
Risk

K141070 is an FDA 510(k) clearance for the SUPER SHEATH. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Bunkyo-Ku, JP). The FDA issued a Cleared decision on January 15, 2015 after a review of 265 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Togo Medikit Co., Ltd. devices

FDA 510(k) Submission Details - K141070

510(k) Number K141070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2014
Decision Date January 15, 2015
Days to Decision 265 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
140d slower than avg
Panel avg: 125d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 87
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K141070.
MicroTract Access System
K151877 · Arstasis, Inc. · Aug 2015
MicroTaper Needle Introducer Set
K151076 · Summit Access, LLC · May 2015
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
K150360 · Spectranetics, Inc. · Mar 2015
Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
K142301 · Cook Vascular, Inc. · Nov 2014
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · Spectranetics, Inc. · Sep 2014
EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
K141148 · Cook Vascular, Inc. · Jul 2014