ITC CATHETERS W/ HYDROMER— 510(k) K922609

Substantially Equivalent

Interventional Therapeutics Corp.

FDA 510(k) clearance K922609 for ITC CATHETERS W/ HYDROMER, Substantially Equivalent on 1993-04-30. Applicant: Interventional Therapeutics Corp..

Clearance details

Applicant: Interventional Therapeutics Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1992-06-02
Decision date: 1993-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.