510(k) K171571
K171571 is an FDA 510(k) premarket notification submitted by Marvao Medical Devices, Ltd. for the device "NexSite HD, Hemodialysis Step Tip Catheter (60cm)". The FDA issued a decision of Substantially Equivalent (kit) on November 30, 2017. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Marvao Medical Devices, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 30, 2017
- Date Received
- May 30, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type