BIVONA CARDEN INTERMITTENT JETTING DEVICE— 510(k) K895946

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K895946 for BIVONA CARDEN INTERMITTENT JETTING DEVICE, Substantially Equivalent on 1990-01-09. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 1989-10-11
Decision date: 1990-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.