Cleared Traditional

K132943 - INTRACARDIC CATHETER INTRODUCER KIT AND...

K132943 is an FDA 510(k) clearance for INTRACARDIC CATHETER INTRODUCER KIT AND..., manufactured by Synaptic Medical Limited. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K132943 · Synaptic Medical Limited · Cardiovascular device
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Aug 2014
Decision
344d
Days
Class 2
Risk

K132943 is an FDA 510(k) clearance for the INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Synaptic Medical Limited (Shanghai, CN). The FDA issued a Cleared decision on August 29, 2014 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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. Elevated predicate reliance profile. 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 - K132943

510(k) Number K132943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2013
Decision Date August 29, 2014
Days to Decision 344 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
219d slower than avg
Panel avg: 125d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 35
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K132943.
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BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208
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