JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS— 510(k) K070234
Substantially EquivalentJms North America Corp.
FDA 510(k) clearance K070234 for JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS, Substantially Equivalent on 2007-05-22. Applicant: Jms North America Corp..
Clearance details
- Applicant
- Jms North America Corp.
- Product code
- Code MPB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hayward, CA, US
Adverse events under product code MPB
product code MPB- Death
- 18
- Malfunction
- 1,042
- Total
- 1,060
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.