J-CATH(TM)— 510(k) K875171

Substantially Equivalent

Hdc Corp.

FDA 510(k) clearance K875171 for J-CATH(TM), Substantially Equivalent on 1988-04-06. Applicant: Hdc Corp..

Clearance details

Applicant: Hdc Corp.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1987-12-17
Decision date: 1988-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.