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FDA 510(k)

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS

K-Number: K023162 · 2003-03-20

ApplicantFresenius Medical Care
Decision Date2003-03-20
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care. It received FDA 510(k) clearance on 2003-03-20 under 510(k) number K023162. 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 FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS?

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS is a medical device that received FDA 510(k) clearance on 2003-03-20. The listed applicant is Fresenius Medical Care. The 510(k) number is K023162.

When did FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS receive FDA 510(k) clearance?

FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS received FDA 510(k) clearance on 2003-03-20, under 510(k) number K023162.

Who is the listed applicant for FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS?

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

What is the FDA product code for FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS?

The FDA product code for FRESENIUS PUNCTUR-GUARD FISTULA NEEDLE SETS is FIE.

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Other records listing Fresenius Medical Care 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.

K2315345008X Hemodialysis SystemK111639FRESENIUS 2008T HEMODIALYSIS MACHINEK030497FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESK022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORK994267FRESENIUS 2008K

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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