PowerWire Radiofrequency Guidewire Kit— 510(k) K232562

Name: FDA 510(k) clearance K232562
Creator: U.S. Food and Drug Administration
Published: 2024-02-28

Unknown

Baylis Medical Technologies, Inc.

FDA 510(k) clearance K232562 for PowerWire Radiofrequency Guidewire Kit, Unknown on 2024-02-28. Applicant: Baylis Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Baylis Medical Technologies, Inc.
Product code: Code PDU
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2023-08-24
Decision date: 2024-02-28
Decision: Unknown
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code PDU

product code PDU

Malfunction: 793
Total: 793

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 →

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