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FDA 510(k)

ANGIOMED HARZMANN DISCS

K-Number: K855077 · 1986-01-21

ApplicantAngiomed U.S., Inc.
Decision Date1986-01-21
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANGIOMED HARZMANN DISCS is the device name listed in this FDA 510(k) record. The listed applicant is Angiomed U.S., Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K855077. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOMED HARZMANN DISCS?

ANGIOMED HARZMANN DISCS is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K855077.

When did ANGIOMED HARZMANN DISCS receive FDA 510(k) clearance?

ANGIOMED HARZMANN DISCS received FDA 510(k) clearance on 1986-01-21, under 510(k) number K855077.

Who is the listed applicant for ANGIOMED HARZMANN DISCS?

The FDA 510(k) record lists Angiomed U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANGIOMED HARZMANN DISCS?

The FDA product code for ANGIOMED HARZMANN DISCS is KOD.

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Other records listing Angiomed U.S., 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.

K874771ANGIOMED INTRODUCING SETSK874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEK864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTK863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSK862805ANGIOMED VAC-U-CUT BIOPSY NEEDLEK863446ANGIOMED HIGH PRESSURE CONNECTORS

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, 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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