ITC ANGIOGRAPHIC CATHETER— 510(k) K900757

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K900757 for ITC ANGIOGRAPHIC CATHETER, Substantially Equivalent on 1990-08-14. Applicant: Interventional Therapeutics Corp..

Clearance details

Applicant
Interventional Therapeutics Corp.
Product code
Code DQA
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South San Francisco, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DQA

product code DQA
Death
66
Malfunction
2,867
Other
1
Total
2,934

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.