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FDA 510(k)

OCCLUSION BALLOON CATHETER

K-Number: K960832 · 1996-05-29

ApplicantInterventional Therapeutics Corp.
Decision Date1996-05-29
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1996-05-29 under 510(k) number K960832. 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 OCCLUSION BALLOON CATHETER?

OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1996-05-29. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K960832.

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

OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 1996-05-29, under 510(k) number K960832.

Who is the listed applicant for OCCLUSION BALLOON CATHETER?

The FDA 510(k) record lists Interventional Therapeutics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCCLUSION BALLOON CATHETER?

The FDA product code for OCCLUSION BALLOON CATHETER is MJN.

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Other records listing Interventional Therapeutics Corp. 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.

K950398CATHETER, BALLOON TYPEK945588DISPOSABLE 1CC SYRINGE WITH LUER LOCKK944354CONTOUR EMBOLIK930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATORK914866ITC CONTOUR EMBOLI, MODIFICATIONK931025INTHERM STASIS VALVE SYSTEM

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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

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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