SUPRAPUBIC CATHETER AND INTRODUCER SET

Catheter, Suprapubic (and Accessories)

MEDIPLUS LTD.

The following data is part of a premarket notification filed by Mediplus Ltd. with the FDA for Suprapubic Catheter And Introducer Set.

Pre-market Notification Details

Device IDK132890
510k NumberK132890
Device Name:SUPRAPUBIC CATHETER AND INTRODUCER SET
ClassificationCatheter, Suprapubic (and Accessories)
Applicant MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks,  GB Hp12 35u
ContactPaul Dryden
CorrespondentPaul Dryden
MEDIPLUS LTD. UNIT 7, THE GATEWAY CENTRE CORONATION RD, CRESSEX BUS. PK. High Wycombe, Bucks,  GB Hp12 35u
Product CodeKOB  
CFR Regulation Number876.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-16
Decision Date2014-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15055140702262 K132890 000
15055140700107 K132890 000
15055140700114 K132890 000
15055140701197 K132890 000
15055140701203 K132890 000
15055140701210 K132890 000
15055140701227 K132890 000
15055140701333 K132890 000
15055140701340 K132890 000
15055140701609 K132890 000
15055140702231 K132890 000
15055140700091 K132890 000

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