V8 TRANSLUMINAL BAV CATHETER— 510(k) K133607
Substantially EquivalentIntervalve, Inc.
FDA 510(k) clearance K133607 for V8 TRANSLUMINAL BAV CATHETER, Substantially Equivalent on 2014-02-11. 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
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code OZT
view allMore clearances from Intervalve, Inc.
view allAdverse 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 →
Recalls naming K133607
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.