SOFTIP CATHETER— 510(k) K834275

Substantially Equivalent

Angiomedics, Inc.

FDA 510(k) clearance K834275 for SOFTIP CATHETER, Substantially Equivalent on 1984-02-04. Applicant: Angiomedics, Inc..

Clearance details

Applicant: Angiomedics, Inc.
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1983-12-08
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.