Cleared Traditional

K233433 - Sphere-9Dx Diagnostic Catheter (AFR-00009)

K233433 is an FDA 510(k) clearance for Sphere-9Dx Diagnostic Catheter (AFR-00009), manufactured by Medtronic. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K233433 · Medtronic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
300d
Days
Class 2
Risk

K233433 is an FDA 510(k) clearance for the Sphere-9Dx Diagnostic Catheter (AFR-00009). Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on August 7, 2024 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

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 Medtronic devices

FDA 510(k) Submission Details - K233433

510(k) Number K233433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2023
Decision Date August 07, 2024
Days to Decision 300 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
175d slower than avg
Panel avg: 125d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MTD Device Classification - Class 2, Special Controls

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
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 - MTD Catheter, Intracardiac Mapping, High-density Array

All 32
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K233433.
OptiMap Catheter - 60mm (OPTI-CATH2-60)
K261012 · Cortex, Inc. · Apr 2026
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · Cortex, Inc. · Mar 2026
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
K241372 · Abbott Medical · Jul 2024
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
K231312 · Biosense Webster, Inc. · Jul 2023
Ablacath™ Mapping Catheter
K223666 · Ablacon, Inc. · Mar 2023
OPTRELL™ Mapping Catheter with TRUEref™ Technology
K230253 · Biosense Webster, Inc. · Mar 2023