CATHETER, INTRAVASCULAR OR PERCUTANEOUS— 510(k) K951078

Substantially Equivalent

Sims Deltec, Inc.

FDA 510(k) clearance K951078 for CATHETER, INTRAVASCULAR OR PERCUTANEOUS, Substantially Equivalent on 1995-07-31. Applicant: Sims Deltec, Inc..

Clearance details

Applicant: Sims Deltec, Inc.
Product code: Code LJS
Advisory panel: General Hospital
Date received: 1995-03-09
Decision date: 1995-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, 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.