CATHETER CARE KITS— 510(k) K894611

Unknown

L H M Ent., Inc.

FDA 510(k) clearance K894611 for CATHETER CARE KITS, Unknown on 1989-12-15. Applicant: L H M Ent., Inc..

Clearance details

Applicant
L H M Ent., Inc.
Product code
Code FOZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Indian Mills, NJ, US
Download summary PDFView 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, through . 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.