MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO— 510(k) K134019
Substantially EquivalentNxstage Medical, Inc.
FDA 510(k) clearance K134019 for MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO, Substantially Equivalent on 2014-09-11. Applicant: Nxstage Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Nxstage Medical, Inc.
- 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
- Traditional
- Location
- Lawrence, MA, US
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More clearances from Nxstage Medical, Inc.
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.