KEYST0NE MEDICAL PICC CATHETER— 510(k) K011860

Substantially Equivalent

Keystone Medical

FDA 510(k) clearance K011860 for KEYST0NE MEDICAL PICC CATHETER, Substantially Equivalent on 2001-06-27. Applicant: Keystone Medical.

Clearance details

Applicant: Keystone Medical
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2001-06-14
Decision date: 2001-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.