JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200— 510(k) K982136

Name: FDA 510(k) clearance K982136
Creator: U.S. Food and Drug Administration
Published: 1999-03-24

Substantially Equivalent

Schiff & Co.

FDA 510(k) clearance K982136 for JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200, Substantially Equivalent on 1999-03-24. Applicant: Schiff & Co.. Device class: 2.

Clearance details

Applicant: Schiff & Co.
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
Advisory panel: Cardiovascular
Date received: 1998-06-17
Decision date: 1999-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Cadwell, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.