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FDA 510(k)

DELTA-A.V. FISTULA CANNULATION SET

K-Number: K812621 · 1981-09-24

ApplicantAmisco Trading Corp.
Decision Date1981-09-24
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DELTA-A.V. FISTULA CANNULATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Amisco Trading Corp.. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812621. 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 DELTA-A.V. FISTULA CANNULATION SET?

DELTA-A.V. FISTULA CANNULATION SET is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is Amisco Trading Corp.. The 510(k) number is K812621.

When did DELTA-A.V. FISTULA CANNULATION SET receive FDA 510(k) clearance?

DELTA-A.V. FISTULA CANNULATION SET received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812621.

Who is the listed applicant for DELTA-A.V. FISTULA CANNULATION SET?

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

What is the FDA product code for DELTA-A.V. FISTULA CANNULATION SET?

The FDA product code for DELTA-A.V. FISTULA CANNULATION SET is FIE.

Related Clinical Trials

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.

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Other records listing Amisco Trading Corp. 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.

K812622HEMODIALYSIS VENOUS & ARTERIAL SET

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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