GRANTALDER RHAPSODY ACCESS PORT AND CATHETER— 510(k) K043178

Substantially Equivalent

Grantadler Corportation

FDA 510(k) clearance K043178 for GRANTALDER RHAPSODY ACCESS PORT AND CATHETER, Substantially Equivalent on 2006-02-02. Applicant: Grantadler Corportation.

Clearance details

Applicant: Grantadler Corportation
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2004-11-16
Decision date: 2006-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorkville, IL, 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.