BD Prevue II Peripheral Vascular Access System— 510(k) K240146
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K240146 for BD Prevue II Peripheral Vascular Access System, Substantially Equivalent on 2024-02-18. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, Inc.
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake Ciy,, UT, US
Recent devices under product code IYO
view allMore clearances from Bard Access Systems, Inc.
view all- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
- K251253 — PowerPort isp Implantable Port +3 more
- K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K222232 — Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.