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FDA 510(k)

MEDISYSTEMS BUTTONHOLE NEEDLE SETS

K-Number: K990803 · 2000-01-06

ApplicantMedisystems Corp.
Decision Date2000-01-06
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEMS BUTTONHOLE NEEDLE SETS is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 2000-01-06 under 510(k) number K990803. 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 MEDISYSTEMS BUTTONHOLE NEEDLE SETS?

MEDISYSTEMS BUTTONHOLE NEEDLE SETS is a medical device that received FDA 510(k) clearance on 2000-01-06. The listed applicant is Medisystems Corp.. The 510(k) number is K990803.

When did MEDISYSTEMS BUTTONHOLE NEEDLE SETS receive FDA 510(k) clearance?

MEDISYSTEMS BUTTONHOLE NEEDLE SETS received FDA 510(k) clearance on 2000-01-06, under 510(k) number K990803.

Who is the listed applicant for MEDISYSTEMS BUTTONHOLE NEEDLE SETS?

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

What is the FDA product code for MEDISYSTEMS BUTTONHOLE NEEDLE SETS?

The FDA product code for MEDISYSTEMS BUTTONHOLE NEEDLE SETS is FIE.

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Other records listing Medisystems 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.

K062953MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICEK010279MEDISYSTEMS LUER ACCESS INJECTION SITEK002372ACCESS ALERT GAUGEK994306REVERSOK983076MEDISYSTEMS TRANSDUCER PROTECTORK971860MEDISYSTEMS DIALYSIS PRIMING SETS

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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

View on FDA Database →

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

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