Cleared Traditional

K233900 - Nordica PV Cryo Mapping Catheter

K233900 is an FDA 510(k) clearance for Nordica PV Cryo Mapping Catheter, manufactured by Synaptic Medical Corporation. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K233900 · Synaptic Medical Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
270d
Days
Class 2
Risk

K233900 is an FDA 510(k) clearance for the Nordica PV Cryo Mapping Catheter. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2024 after a review of 270 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 Corporation devices

FDA 510(k) Submission Details - K233900

510(k) Number K233900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2023
Decision Date September 06, 2024
Days to Decision 270 days
Submission Type Traditional
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
145d slower than avg
Panel avg: 125d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 98
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K233900.
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