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FDA 510(k)

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS

K-Number: K772362 · 1978-03-17

ApplicantTerumo America, Inc.
Decision Date1978-03-17
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1978-03-17 under 510(k) number K772362. The device is classified under product code FIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVF SET FOR SINGLE NEEDLE HEMODIALYSIS?

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is Terumo America, Inc.. The 510(k) number is K772362.

When did AVF SET FOR SINGLE NEEDLE HEMODIALYSIS receive FDA 510(k) clearance?

AVF SET FOR SINGLE NEEDLE HEMODIALYSIS received FDA 510(k) clearance on 1978-03-17, under 510(k) number K772362.

Who is the listed applicant for AVF SET FOR SINGLE NEEDLE HEMODIALYSIS?

The FDA 510(k) record lists Terumo America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVF SET FOR SINGLE NEEDLE HEMODIALYSIS?

The FDA product code for AVF SET FOR SINGLE NEEDLE HEMODIALYSIS is FIE.

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Other records listing Terumo America, Inc. 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK801192CLIRANS TE10 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZER

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Related Devices (Code: FIE)

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.

K253469Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM)Mozarc Medical Us, LLCK251877JMS CAVEO A.V. Fistula Needle SetJMS North America CorporationK213015DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K171505Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)Dimesol, Inc.K163025DORA Disposable A.V. Fistula Needle SetsBain Medical Equipment (Guangzhou) Co., Ltd.K112734APLAN A.V. FISTULA NEEDLE SETAplan Well Enterprise Co., 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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