MAGIC INFUSION CATHETER— 510(k) K923368

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K923368 for MAGIC INFUSION CATHETER, Substantially Equivalent on 1993-04-07. Applicant: Target Therapeutics.

Clearance details

Applicant
Target Therapeutics
Product code
Code KRA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Freemont, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code KRA

product code KRA
Death
234
Injury
1,029
Malfunction
3,012
Other
2
Total
4,277

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.