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FDA 510(k)

A.V. FISTULA NEEDLE SET (#361)

K-Number: K771495 · 1977-08-16

ApplicantSorensen Research
Decision Date1977-08-16
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

A.V. FISTULA NEEDLE SET (#361) is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771495. 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 A.V. FISTULA NEEDLE SET (#361)?

A.V. FISTULA NEEDLE SET (#361) is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Sorensen Research. The 510(k) number is K771495.

When did A.V. FISTULA NEEDLE SET (#361) receive FDA 510(k) clearance?

A.V. FISTULA NEEDLE SET (#361) received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771495.

Who is the listed applicant for A.V. FISTULA NEEDLE SET (#361)?

The FDA 510(k) record lists Sorensen Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.V. FISTULA NEEDLE SET (#361)?

The FDA product code for A.V. FISTULA NEEDLE SET (#361) is FIE.

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Other records listing Sorensen Research as applicant

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K833674ACCURATE MEASUREMENT DEVICE KG-AMDK833673ACCURATE MEASUREMENT DEVICE EZ-AMDK833094TRANSDUCER DOME SD104K833096TRANSDUCER DOME DS106K833095TRANSDUCER DOME SD105K832957FLOW-DIRECTED HEPARIN COATED THERMODIL

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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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