VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER— 510(k) K981994

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K981994 for VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER, Substantially Equivalent on 1998-09-03. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 1998-06-08
Decision date: 1998-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.