JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)— 510(k) K142564
Substantially EquivalentJMS North America Corporation
FDA 510(k) clearance K142564 for JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4), Substantially Equivalent on 2014-12-23. Applicant: JMS North America Corporation. Device class: 2.
Clearance details
- Applicant
- JMS North America Corporation
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hayward, CA, US
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More clearances from JMS North America Corporation
view allAdverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
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.