Cleared Traditional

K223824 - POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor

K223824 is an FDA 510(k) clearance for POLARSHEATH Steerable Sheath 12F (UPN:M..., manufactured by Boston Scientific Corporation. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ 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

FDA 510(k) Submission Details - K223824

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.

DRA Device Classification - Class 2, Special Controls

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 29
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
FARADRIVE™ Steerable Sheath
K233248 · Boston Scientific Corporation · Dec 2023
FlexCath Contour™ 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