DeviceClearance

EPXT Unidirectional Steerable Diagnostic Catheter +2 more— 510(k) K240366

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K240366 for EPXT Unidirectional Steerable Diagnostic Catheter +2 more, Substantially Equivalent on 2024-11-01. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Device name as filed
EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
Applicant
Boston Scientific Corporation
Product code
Code DRF
Device class
Class 2
Regulation
21 CFR 870.1220
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St Paul, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DRF

product code DRF
Death
127
Injury
1,676
Malfunction
2,003
Other
1
Total
3,807

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

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