Chrysalis Intelligence · Sponsors · Rocket Medical Plc

Rocket Medical Plc

Washington, GB · 1 510(k) clearances · 6 recalls

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Total clearances
1
2021-09-09 → 2021-09-09
Last 12 months
0
Product codes
1
Most recent
2021-09-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DWM Apparatus, Suction, Patient Care Class II Cardiovascular 1 2021-09-09
Safety

Recalls (6)

Class I (serious)
0
Risk of injury / death
Total recalls
6
Currently ongoing
6
Most recent
2025-11-07
DateSeverityStatusRecall # ProductCodeReason
2025-11-07 Class II Ongoing Z-0955-2026 Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Sof… — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07 Class II Ongoing Z-0954-2026 Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Sof… — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07 Class II Ongoing Z-0953-2026 Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG … — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07 Class II Ongoing Z-0952-2026 Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Sof… — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07 Class II Ongoing Z-0951-2026 Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG … — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
2025-11-07 Class II Ongoing Z-0950-2026 Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Pro… — IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-09-09 K210509 Rocket Platinum Cured Cathter DWM Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence