Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more— 510(k) K253469
Substantially EquivalentMozarc Medical Us, LLC
FDA 510(k) clearance K253469 for Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM) +5 more, Substantially Equivalent on 2026-08-06. Applicant: Mozarc Medical Us, LLC. Device class: 2.
Clearance details
- Device name as filed
- Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)
- Applicant
- Mozarc Medical Us, LLC
- 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
- Mansfield, MA, US
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Adverse 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.