BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES— 510(k) K001390

Substantially Equivalent

Biosense Webster, Inc.

FDA 510(k) clearance K001390 for BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES, Substantially Equivalent on 2000-07-21. Applicant: Biosense Webster, Inc..

Clearance details

Applicant: Biosense Webster, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2000-05-02
Decision date: 2000-07-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Diamond Bar, CA, US

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.