DeviceClearance

V8 Transluminal BAV Catheter— 510(k) K150343

Substantially Equivalent

Intervalve, Inc.

FDA 510(k) clearance K150343 for V8 Transluminal BAV Catheter, Substantially Equivalent on 2015-04-03. Applicant: Intervalve, Inc.. Device class: 2.

Clearance details

Applicant
Intervalve, Inc.
Product code
Code OZT
Device class
Class 2
Regulation
21 CFR 870.1255
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plymouth, MN, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OZT

product code OZT
Death
20
Other
2
Total
22

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 →

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