SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200— 510(k) K911876

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K911876 for SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200, Substantially Equivalent on 1991-08-09. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1991-04-29
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.