CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH— 510(k) K926139

Substantially Equivalent

Bard Access Systems, Inc.

FDA 510(k) clearance K926139 for CATHLINK 20 TITANIUM PORT W/ATT. POLYURETHANE CATH, Substantially Equivalent on 1995-01-03. Applicant: Bard Access Systems, Inc..

Clearance details

Applicant: Bard Access Systems, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1992-12-07
Decision date: 1995-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.