STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM— 510(k) K953436

Substantially Equivalent

Strato/Infusaid, Inc.

FDA 510(k) clearance K953436 for STRATO/INFUSAID INFUSE-A-CATH SINGLE LUMEN SILICONE CENTRAL VENOUS CATHETER SYSTESM, Substantially Equivalent on 1995-10-04. Applicant: Strato/Infusaid, Inc..

Clearance details

Applicant: Strato/Infusaid, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1995-07-21
Decision date: 1995-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwood, MA, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.