SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE— 510(k) K120882
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K120882 for SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE, Substantially Equivalent on 2012-05-30. 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
- Traditional
- Location
- Salt Lake Ciy,, UT, US
Recent devices under product code IYO
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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.