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FDA 510(k)

SHARGHP A.V. FISTULA NEEDLE SET

K-Number: K013384 · 2002-01-07

ApplicantShargh Pharmaceutical Co., Inc.
Decision Date2002-01-07
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHARGHP A.V. FISTULA NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Shargh Pharmaceutical Co., Inc.. It received FDA 510(k) clearance on 2002-01-07 under 510(k) number K013384. 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 SHARGHP A.V. FISTULA NEEDLE SET?

SHARGHP A.V. FISTULA NEEDLE SET is a medical device that received FDA 510(k) clearance on 2002-01-07. The listed applicant is Shargh Pharmaceutical Co., Inc.. The 510(k) number is K013384.

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

SHARGHP A.V. FISTULA NEEDLE SET received FDA 510(k) clearance on 2002-01-07, under 510(k) number K013384.

Who is the listed applicant for SHARGHP A.V. FISTULA NEEDLE SET?

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

What is the FDA product code for SHARGHP A.V. FISTULA NEEDLE SET?

The FDA product code for SHARGHP A.V. FISTULA NEEDLE 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 Shargh Pharmaceutical Co., 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.

K895980SHARGHP INSULIN SYRINGESK895810SHARGHP SYRINGES, WITH AND WITHOUT NEEDLEK895812SHARGHP INTRAVENOUS CATHETERK895811SHARGHP HYPODERMIC NEEDLE

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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