DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)— 510(k) K091760

Substantially Equivalent

Dermaport, Inc.

FDA 510(k) clearance K091760 for DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS), Substantially Equivalent on 2009-07-20. Applicant: Dermaport, Inc..

Clearance details

Applicant: Dermaport, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2009-06-16
Decision date: 2009-07-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clarita, CA, US

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Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.