KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER— 510(k) K973546

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K973546 for KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER, Substantially Equivalent on 1997-11-07. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 1997-09-18
Decision date: 1997-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.