Rocket Platinum Cured Cathter

Apparatus, Suction, Patient Care

Rocket Medical Plc

The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Rocket Platinum Cured Cathter.

Pre-market Notification Details

Device IDK210509
510k NumberK210509
Device Name:Rocket Platinum Cured Cathter
ClassificationApparatus, Suction, Patient Care
Applicant Rocket Medical Plc 2-4 Sedling Road Washington,  GB Ne38 9bz
ContactTracy Charlton
CorrespondentTracy Charlton
Rocket Medical Plc 2-4 Sedling Road Washington,  GB Ne38 9bz
Product CodeDWM  
CFR Regulation Number870.5050 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-22
Decision Date2021-09-09

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