INTROSTAT LEAD INTRODUCER— 510(k) K960200

Name: FDA 510(k) clearance K960200
Creator: U.S. Food and Drug Administration
Published: 1996-07-02

Substantially Equivalent

Msi, Inc.

FDA 510(k) clearance K960200 for INTROSTAT LEAD INTRODUCER, Substantially Equivalent on 1996-07-02. Applicant: Msi, Inc.. Device class: 2.

Clearance details

Applicant: Msi, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1996-01-03
Decision date: 1996-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarpon Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.