VASCUTEK VASCULAR PROTHESIS VP1200K/50K— 510(k) K830016

Name: FDA 510(k) clearance K830016
Creator: U.S. Food and Drug Administration
Published: 1983-12-21

Substantially Equivalent

Pacesetter Systems

FDA 510(k) clearance K830016 for VASCUTEK VASCULAR PROTHESIS VP1200K/50K, Substantially Equivalent on 1983-12-21. Applicant: Pacesetter Systems. Device class: 2.

Clearance details

Applicant: Pacesetter Systems
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1983-01-03
Decision date: 1983-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

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Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.