Cleared Traditional

K121504 - SUPER SHEATH INTRODUCER SHEATH AND SUPE...

K121504 is an FDA 510(k) clearance for SUPER SHEATH INTRODUCER SHEATH AND SUPE..., manufactured by Togo Medikit Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K121504 · Togo Medikit Co., Ltd. · Cardiovascular device
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Sep 2012
Decision
129d
Days
Class 2
Risk

K121504 is an FDA 510(k) clearance for the SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Togo Medikit Co., Ltd. (Austin, US). The FDA issued a Cleared decision on September 27, 2012 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 - K121504

510(k) Number K121504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2012
Decision Date September 27, 2012
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 433
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K121504.
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K122190 · Merit Medical Systems, Inc. · Aug 2012