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.. Device class: 2.

Clearance details

Applicant
Interventional Therapeutics Corp.
Product code
Code DQA
Device class
Class 2
Regulation
21 CFR 870.2700
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 ↗

Recent devices under product code DQA

view all

More clearances from Interventional Therapeutics Corp.

view all

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.