Cleared Traditional

K223824 - POLARSHEATHâ„¢ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPâ„¢ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAPâ„¢ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZEâ„¢ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZEâ„¢ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZEâ„¢ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZEâ„¢ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZEâ„¢ Pressure Sensor (FDA 510(k) Clearance)

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

K223824 · Boston Scientific Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
91d
Days
Class 2
Risk

K223824 is an FDA 510(k) clearance for the POLARSHEATHâ„¢ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAPâ„¢ Circular Mapp.... Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on March 22, 2023 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - 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 Boston Scientific Corporation devices

Submission Details

510(k) Number K223824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2022
Decision Date March 22, 2023
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K223824.
Globe Introducer (601-01001)
K250529 · Kardium, Inc. · Jun 2025
FARADRIVEâ„¢ Steerable Sheath
K233248 · Boston Scientific Corporation · Dec 2023
FlexCath Contourâ„¢ Steerable Sheath
K232321 · Medtronic, Inc. · Oct 2023
MitraClip G4 Steerable Guide Catheter
K221397 · Abbott Medical · Sep 2022
AcQGuide® VUE Steerable Sheath
K221044 · Acutus Medical, Inc. · May 2022
AcQGuide MAX Steerable Sheath
K211100 · Acutus Medical, Inc. · May 2021