NexSite HD, Hemodialysis Step Tip Catheter (60cm)— 510(k) K171571
UnknownMarvao Medical Devices, Ltd.
FDA 510(k) clearance K171571 for NexSite HD, Hemodialysis Step Tip Catheter (60cm), Unknown on 2017-11-30. Applicant: Marvao Medical Devices, Ltd.. Device class: 2.
Clearance details
- Applicant
- Marvao Medical Devices, Ltd.
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Special
- Location
- Galway, IE
Recent devices under product code MSD
view allMore clearances from Marvao Medical Devices, Ltd.
view all- K220632 — Boss Crossing Support Catheter
- K173805 — NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
- K161026 — NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)
- K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
- K140492 — NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
Adverse events under product code MSD
product code MSD- Death
- 67
- Injury
- 545
- Malfunction
- 3,661
- Total
- 4,273
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.