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FDA 510(k)

KAVS - CATHETER, MODELS 1107100 & 1107060

K-Number: K052844 · 2006-03-20

ApplicantRichter & Rothe AG
Decision Date2006-03-20
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KAVS - CATHETER, MODELS 1107100 & 1107060 is the device name listed in this FDA 510(k) record. The listed applicant is Richter & Rothe AG. It received FDA 510(k) clearance on 2006-03-20 under 510(k) number K052844. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAVS - CATHETER, MODELS 1107100 & 1107060?

KAVS - CATHETER, MODELS 1107100 & 1107060 is a medical device that received FDA 510(k) clearance on 2006-03-20. The listed applicant is Richter & Rothe AG. The 510(k) number is K052844.

When did KAVS - CATHETER, MODELS 1107100 & 1107060 receive FDA 510(k) clearance?

KAVS - CATHETER, MODELS 1107100 & 1107060 received FDA 510(k) clearance on 2006-03-20, under 510(k) number K052844.

Who is the listed applicant for KAVS - CATHETER, MODELS 1107100 & 1107060?

The FDA 510(k) record lists Richter & Rothe AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAVS - CATHETER, MODELS 1107100 & 1107060?

The FDA product code for KAVS - CATHETER, MODELS 1107100 & 1107060 is MJN.

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Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

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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