FDA 510(k)

TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE

K-Number: K844343 · 1985-01-08

Decision Date1985-01-08

Product CodeFIE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Top Surgical Manufacturers Co.. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844343. 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 TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE?

TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Top Surgical Manufacturers Co.. The 510(k) number is K844343.

When did TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE receive FDA 510(k) clearance?

TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844343.

Who is the listed applicant for TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE?

The FDA 510(k) record lists Top Surgical Manufacturers Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE?

The FDA product code for TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE is FIE.

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Other records listing Top Surgical Manufacturers Co. as applicant

K843415TOP HYPODERMIC SYRINGE LUER LOCK K843313TOP DISPOSABLE SPINAL NEEDLE K843414TOP HYPODERMIC SYRINGE PISTON K841119TOPS DISPOS. INFUSION SET/HEMODIALYSIS K841025TOP DISPOSABLE INFUSION SET K832624TOP VENULA I.V. CATHETER SET

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Related Devices (Code: FIE)

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, LLC K251877JMS CAVEO A.V. Fistula Needle SetJMS North America Corporation K213015DORA 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.