LIFEPORT VASCULAR ACCESS PORT— 510(k) K895689

Substantially Equivalent

Strato Medical Corp.

FDA 510(k) clearance K895689 for LIFEPORT VASCULAR ACCESS PORT, Substantially Equivalent on 1989-12-27. Applicant: Strato Medical Corp..

Clearance details

Applicant: Strato Medical Corp.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1989-09-22
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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.