DeviceClearance

BLOW-SINGER TRACHEOSTOMA VALVE— 510(k) K821568

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K821568 for BLOW-SINGER TRACHEOSTOMA VALVE, Substantially Equivalent on 1982-07-26. Applicant: Bivona Medical Technologies. Device class: 2.

Clearance details

Applicant
Bivona Medical Technologies
Product code
Code EWL
Device class
Class 2
Regulation
21 CFR 874.3730
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code EWL

view all

More clearances from Bivona Medical Technologies

view all

Adverse events under product code EWL

product code EWL
Death
2
Total
2

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K821568

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K821568.

Data sourced from openFDA. This site is unofficial and independent of the FDA.