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— 510(k) K223824

Name: FDA 510(k) clearance K223824
Creator: U.S. Food and Drug Administration
Published: 2023-03-22

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K223824 for 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, Substantially Equivalent on 2023-03-22. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code DRA
Device class: Class 2
Regulation: 21 CFR 870.1280
Advisory panel: Cardiovascular
Date received: 2022-12-21
Decision date: 2023-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DRA

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K262165 — FARADRIVE Steerable Sheath (M004PF21M402)2026-07-24
K250529 — Globe Introducer (601-01001)2025-06-03
K233248 — FARADRIVE Steerable Sheath2023-12-11
K232321 — FlexCath Contour Steerable Sheath2023-10-31
K221397 — MitraClip G4 Steerable Guide Catheter2022-09-28

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K261488 — OBSIDIO Conformable Embolic2026-07-24
K262462 — TheraSphere 360 Y-90 Management Platform2026-07-24

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K223824

K-number listed on FDA's recall record

Z-1302-2024 — Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Class I·Ongoing·Boston Scientific Corporation·20240212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223824.

Data sourced from openFDA. This site is unofficial and independent of the FDA.