Cleared Special

Super Sheath (K200379) - FDA 510(k) Clearance

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

K200379 · Togo Medikit Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
30d
Days
Class 2
Risk

K200379 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. (Hyuga City, JP). The FDA issued a Cleared decision on March 19, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 K200379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2020
Decision Date March 19, 2020
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Mic International
Izumi Maruo

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 32
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K200379.
Endovascular Dilator and Sets
K210734 · Cook Incorporated · Apr 2021
ExpanSure Large Access Transseptal Dilator
K201288 · Baylis Medical Company, Inc. · Jun 2020
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
K192283 · Medron, LLC · May 2020
Sterile Dilator
K192195 · Galt Medical Corp. · Sep 2019
S-MAK XL
K190175 · Merit Medical Systems, Inc. · Apr 2019
ExpanSure Transseptal Dilation System
K182064 · Baylis Medical Company, Inc. · Mar 2019