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FDA 510(k)

PORT ACCESS INFUSION SET

K-Number: K921901 · 1993-09-10

ApplicantKawasumi Laboratories Co., Ltd.
Decision Date1993-09-10
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PORT ACCESS INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1993-09-10 under 510(k) number K921901. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORT ACCESS INFUSION SET?

PORT ACCESS INFUSION SET is a medical device that received FDA 510(k) clearance on 1993-09-10. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K921901.

When did PORT ACCESS INFUSION SET receive FDA 510(k) clearance?

PORT ACCESS INFUSION SET received FDA 510(k) clearance on 1993-09-10, under 510(k) number K921901.

Who is the listed applicant for PORT ACCESS INFUSION SET?

The FDA 510(k) record lists Kawasumi Laboratories Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORT ACCESS INFUSION SET?

The FDA product code for PORT ACCESS INFUSION SET is FRN.

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Other records listing Kawasumi Laboratories Co., 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.

K994323KAWASUMI LABORATORIES PHILEBOTOMY SETK974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITEK935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDERK935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERK935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

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Related Devices (Code: FRN)

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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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