STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF— 510(k) K905849

Unknown

Strato Medical Corp.

FDA 510(k) clearance K905849 for STRATO PLASTIC PORT INTRO KT(10 FR) LPS 7523/MODIF, Unknown on 1991-04-19. Applicant: Strato Medical Corp..

Clearance details

Applicant: Strato Medical Corp.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1990-12-27
Decision date: 1991-04-19
Decision: Unknown
Clearance type: Traditional
Location: Beverly, MA, 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.