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FDA 510(k)

THE BELLCO FISTULA NEEDLES

K-Number: K801632 · 1980-08-04

ApplicantBellco Artifidial Organ Spec., Inc.
Decision Date1980-08-04
Product CodeFIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE BELLCO FISTULA NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Artifidial Organ Spec., Inc.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801632. 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 THE BELLCO FISTULA NEEDLES?

THE BELLCO FISTULA NEEDLES is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Bellco Artifidial Organ Spec., Inc.. The 510(k) number is K801632.

When did THE BELLCO FISTULA NEEDLES receive FDA 510(k) clearance?

THE BELLCO FISTULA NEEDLES received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801632.

Who is the listed applicant for THE BELLCO FISTULA NEEDLES?

The FDA 510(k) record lists Bellco Artifidial Organ Spec., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE BELLCO FISTULA NEEDLES?

The FDA product code for THE BELLCO FISTULA NEEDLES is FIE.

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Other records listing Bellco Artifidial Organ Spec., 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.

K801633THE BRAVO NEW PARALLEL FLOW DIALYZERK801634THE VITA 2 DISPOSABLE DIALYZER

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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