Cleared Traditional

K132943 - INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 50
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