Chrysalis Intelligence · Sponsors · Marvao Medical Devices, Ltd.

Marvao Medical Devices, Ltd.

Galway, IE · 1 510(k) clearances · 1 recalls

Total clearances
1
2022-06-02 → 2022-06-02
Last 12 months
0
Product codes
1
Most recent
2022-06-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQY Catheter, Percutaneous Class II Cardiovascular 1 2022-06-02
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2020-02-11
DateSeverityStatusRecall # ProductCodeReason
2020-02-11 Class II Ongoing Z-1699-2021 NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use — The action is to ensure consistency between the Directions for Use (DFU) in the field and the DFU on the website.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-06-02 K220632 Boss Crossing Support Catheter DQY Class II Cardiovascular