Cleared Traditional

K151936 - Steerable Intracardiac Catheter Introdu...

K151936 is an FDA 510(k) clearance for Steerable Intracardiac Catheter Introdu..., manufactured by Synaptic Medical Limited. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K151936 · Synaptic Medical Limited · Cardiovascular device
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Dec 2015
Decision
143d
Days
Class 2
Risk

K151936 is an FDA 510(k) clearance for the Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Synaptic Medical Limited (Beijing, CN). The FDA issued a Cleared decision on December 4, 2015 after a review of 143 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 Synaptic Medical Limited devices

FDA 510(k) Submission Details - K151936

510(k) Number K151936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 14, 2015
Decision Date December 04, 2015
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
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 483
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K151936.
GORE DrySeal Flex Introducer Sheath
K160254 · W.L. Gore & Associates, Inc. · May 2016
The Nanostim Introducer Kit
K160716 · St. Jude Medical, Inc. · Apr 2016
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
K153430 · Cook Incorporated · Mar 2016
Edwards eSheath Introducer Set
K152225 · Edwards Lifesciences · Nov 2015
Prelude SNAP Splittable Hydrophilic Sheath Introducer
K152381 · Merit Medical Systems, Inc. · Oct 2015
Destino Reach
K151951 · Oscor, Inc. · Sep 2015