ENTERAL DELIVERY SETS WITH HYDRATION PORT— 510(k) K943675

Substantially Equivalent

Clintec Technologies, Inc.

FDA 510(k) clearance K943675 for ENTERAL DELIVERY SETS WITH HYDRATION PORT, Substantially Equivalent on 1994-12-30. Applicant: Clintec Technologies, Inc..

Clearance details

Applicant: Clintec Technologies, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1994-07-26
Decision date: 1994-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfiels, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.