NAVAJO PTA BALLOON DILATATION CATHETER— 510(k) K141354

Substantially Equivalent

Curative Medical, Inc.

FDA 510(k) clearance K141354 for NAVAJO PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2015-01-30. Applicant: Curative Medical, Inc..

Clearance details

Applicant: Curative Medical, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2014-05-23
Decision date: 2015-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodbury, 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.