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FDA 510(k)

NEEDLE SET, A-V FISTULA

K-Number: K770699 · 1977-06-14

ApplicantMedical Disposables Intl., Inc.
Decision Date1977-06-14
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE SET, A-V FISTULA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Disposables Intl., Inc.. It received FDA 510(k) clearance on 1977-06-14 under 510(k) number K770699. 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 NEEDLE SET, A-V FISTULA?

NEEDLE SET, A-V FISTULA is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Medical Disposables Intl., Inc.. The 510(k) number is K770699.

When did NEEDLE SET, A-V FISTULA receive FDA 510(k) clearance?

NEEDLE SET, A-V FISTULA received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770699.

Who is the listed applicant for NEEDLE SET, A-V FISTULA?

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

What is the FDA product code for NEEDLE SET, A-V FISTULA?

The FDA product code for NEEDLE SET, A-V FISTULA is FIE.

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Other records listing Medical Disposables Intl., 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.

K771231ARTEOIAL LINE KITK771230PERCUTANEOUS INTRODUCER SHEATH SETK770945POUCH, TYVEK-POLYMYLONK770552CATHETER, KIDNEY DIALYSIS, HEMO-CATH IIK761078HEMO-CATH I, KIDNEY DIALYSIS CATHETER

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

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

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