True Flow Valvuloplasty Perfusion Catheter— 510(k) K152613
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K152613 for True Flow Valvuloplasty Perfusion Catheter, Substantially Equivalent on 2016-01-19. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Tempe, AZ, US
Recent devices under product code OZT
view allMore clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
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.