K974471

Substantially Equivalent

PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW PROFILE SYSTEM WITH INTRODUCER SET, PORT-A

Applicant: Sims Deltec, Inc.
Product code: LJT
Advisory panel: General Hospital
Date received: 1997-11-26
Decision date: 1998-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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.