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FDA 510(k)

MEDISYSTEMS PHERESIS NEEDLE

K-Number: K862002 · 1986-06-27

ApplicantMedisystems Corp.
Decision Date1986-06-27
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MEDISYSTEMS PHERESIS NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medisystems Corp.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K862002. 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 PHERESIS NEEDLE?

MEDISYSTEMS PHERESIS NEEDLE is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Medisystems Corp.. The 510(k) number is K862002.

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

MEDISYSTEMS PHERESIS NEEDLE received FDA 510(k) clearance on 1986-06-27, under 510(k) number K862002.

Who is the listed applicant for MEDISYSTEMS PHERESIS NEEDLE?

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 PHERESIS NEEDLE?

The FDA product code for MEDISYSTEMS PHERESIS NEEDLE 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 GAUGEK994306REVERSOK990803MEDISYSTEMS BUTTONHOLE NEEDLE SETSK983076MEDISYSTEMS TRANSDUCER PROTECTOR

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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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