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FDA 510(k)

TEMPORARY OCCLUSION BALLOON SYSTEM

K-Number: K972777 · 1998-03-11

ApplicantPercu Surge, Inc.
Decision Date1998-03-11
Product CodeMJN
Advisory CommitteeCV
DecisionUnknown

Device Summary

TEMPORARY OCCLUSION BALLOON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Percu Surge, Inc.. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K972777. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TEMPORARY OCCLUSION BALLOON SYSTEM?

TEMPORARY OCCLUSION BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Percu Surge, Inc.. The 510(k) number is K972777.

When did TEMPORARY OCCLUSION BALLOON SYSTEM receive FDA 510(k) clearance?

TEMPORARY OCCLUSION BALLOON SYSTEM received FDA 510(k) clearance on 1998-03-11, under 510(k) number K972777.

Who is the listed applicant for TEMPORARY OCCLUSION BALLOON SYSTEM?

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

What is the FDA product code for TEMPORARY OCCLUSION BALLOON SYSTEM?

The FDA product code for TEMPORARY OCCLUSION BALLOON SYSTEM is MJN.

Related Clinical Trials

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.

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Other records listing Percu Surge, 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.

K003992PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

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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