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FDA 510(k)

ProSeal™ Closed System drug Transfer Device (CSTD)

K-Number: K192075 · 2020-08-07

ApplicantEpic Medical Pte. , Ltd.
Decision Date2020-08-07
Product CodeONB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProSeal™ Closed System drug Transfer Device (CSTD) is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Pte. , Ltd.. It received FDA 510(k) clearance on 2020-08-07 under 510(k) number K192075. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSeal™ Closed System drug Transfer Device (CSTD)?

ProSeal™ Closed System drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is Epic Medical Pte. , Ltd.. The 510(k) number is K192075.

When did ProSeal™ Closed System drug Transfer Device (CSTD) receive FDA 510(k) clearance?

ProSeal™ Closed System drug Transfer Device (CSTD) received FDA 510(k) clearance on 2020-08-07, under 510(k) number K192075.

Who is the listed applicant for ProSeal™ Closed System drug Transfer Device (CSTD)?

The FDA 510(k) record lists Epic Medical Pte. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ProSeal™ Closed System drug Transfer Device (CSTD)?

The FDA product code for ProSeal™ Closed System drug Transfer Device (CSTD) is ONB.

Other records listing Epic Medical Pte. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceK250234SMARTeZ™ Elastomeric Infusion Pump (RS series)K251722ProSeal™ Transfer Injector (421120, 421130, 421140)K251814EZ™ IV Administration SetK252094eZSURE™ Empty Fluid ContainerK251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)

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Related Devices (Code: ONB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251722ProSeal™ Transfer Injector (421120, 421130, 421140)Epic Medical Pte. , Ltd.K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare , Ltd.K250059BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)Becton, Dickinson and CompanyK251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare , Ltd.K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte. , Ltd.K243976ZeroClear™ Bag Access (423100)Epic Medical Pte. , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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