PLASTIC ATTACHABLE DUAL PORT— 510(k) K912702

Substantially Equivalent

Davol, Inc.

FDA 510(k) clearance K912702 for PLASTIC ATTACHABLE DUAL PORT, Substantially Equivalent on 1991-09-18. Applicant: Davol, Inc..

Clearance details

Applicant: Davol, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1991-06-19
Decision date: 1991-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.