SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908— 510(k) K961155

Substantially Equivalent

Douglas Medical Products Corp.

FDA 510(k) clearance K961155 for SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908, Substantially Equivalent on 1996-06-18. Applicant: Douglas Medical Products Corp..

Clearance details

Applicant
Douglas Medical Products Corp.
Product code
Code LJS
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Libertyville, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LJS

product code LJS
Death
31
Injury
2,791
Malfunction
18,374
Other
5
Total
21,201

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.