THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM— 510(k) K933350

Unknown

Therex Corp.

FDA 510(k) clearance K933350 for THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM, Unknown on 1994-02-23. Applicant: Therex Corp..

Clearance details

Applicant: Therex Corp.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1993-07-09
Decision date: 1994-02-23
Decision: Unknown
Clearance type: Traditional
Location: Walpole, 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.