VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES— 510(k) K030005

Substantially Equivalent

Vanguard Medical Concepts, Inc.

FDA 510(k) clearance K030005 for VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES, Substantially Equivalent on 2003-03-18. Applicant: Vanguard Medical Concepts, Inc..

Clearance details

Applicant: Vanguard Medical Concepts, Inc.
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2003-01-02
Decision date: 2003-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeland, FL, 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.