VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}— 510(k) K953394

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K953394 for VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}, Substantially Equivalent on 1995-10-12. Applicant: Visitec Co..

Clearance details

Applicant: Visitec Co.
Product code: Code LZU
Advisory panel: Unknown
Date received: 1995-07-17
Decision date: 1995-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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Adverse events under product code LZU

product code LZU

Other: 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.