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FDA 510(k)

ER-REBOA PLUS Catheter

K-Number: K193440 · 2020-01-09

ApplicantPrytime Medical Devices, Inc.
Decision Date2020-01-09
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ER-REBOA PLUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Prytime Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-01-09 under 510(k) number K193440. 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 ER-REBOA PLUS Catheter?

ER-REBOA PLUS Catheter is a medical device that received FDA 510(k) clearance on 2020-01-09. The listed applicant is Prytime Medical Devices, Inc.. The 510(k) number is K193440.

When did ER-REBOA PLUS Catheter receive FDA 510(k) clearance?

ER-REBOA PLUS Catheter received FDA 510(k) clearance on 2020-01-09, under 510(k) number K193440.

Who is the listed applicant for ER-REBOA PLUS Catheter?

The FDA 510(k) record lists Prytime Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ER-REBOA PLUS Catheter?

The FDA product code for ER-REBOA PLUS Catheter is MJN.

Other records listing Prytime Medical Devices, 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.

K243795pREBOA-PRO CatheterK200459pREBOA-PRO CatheterK172790ER-REBOA CatheterK170411ER-REBOA Catheter

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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