MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER— 510(k) K073423

Substantially Equivalent

C.R. Bard, Inc.

FDA 510(k) clearance K073423 for MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER, Substantially Equivalent on 2007-12-19. Applicant: C.R. Bard, Inc..

Clearance details

Applicant: C.R. Bard, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 2007-12-05
Decision date: 2007-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake Ciy,, 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.