PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K— 510(k) K910315

Unknown

Sorex Medical

FDA 510(k) clearance K910315 for PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K, Unknown on 1991-04-05. Applicant: Sorex Medical.

Clearance details

Applicant: Sorex Medical
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1991-01-24
Decision date: 1991-04-05
Decision: Unknown
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code LJS

product code LJS

Death: 31
Injury: 2,791
Malfunction: 18,374
Other: 5
Total: 21,201

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.