PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV— 510(k) K850888

Substantially Equivalent

Creative Care Systems, Inc.

FDA 510(k) clearance K850888 for PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV, Substantially Equivalent on 1985-05-07. Applicant: Creative Care Systems, Inc..

Clearance details

Applicant: Creative Care Systems, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1985-03-04
Decision date: 1985-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maplewood, NJ, 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.