AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER— 510(k) K042624

Substantially Equivalent

Invatec Innovative Technologies, S.R.L.

FDA 510(k) clearance K042624 for AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER, Substantially Equivalent on 2005-01-10. Applicant: Invatec Innovative Technologies, S.R.L..

Clearance details

Applicant: Invatec Innovative Technologies, S.R.L.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2004-09-27
Decision date: 2005-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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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.