THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012— 510(k) K974475

Substantially Equivalent

Biocontrol Technology, Inc.

FDA 510(k) clearance K974475 for THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012, Substantially Equivalent on 1998-03-02. Applicant: Biocontrol Technology, Inc..

Clearance details

Applicant: Biocontrol Technology, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1997-11-26
Decision date: 1998-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indiana, PA, 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.