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FDA 510(k)

BIPORE BALLOON DILATION CATHETER

K-Number: K073318 · 2008-01-16

ApplicantBipore, Inc.
Decision Date2008-01-16
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIPORE BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Bipore, Inc.. It received FDA 510(k) clearance on 2008-01-16 under 510(k) number K073318. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIPORE BALLOON DILATION CATHETER?

BIPORE BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2008-01-16. The listed applicant is Bipore, Inc.. The 510(k) number is K073318.

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

BIPORE BALLOON DILATION CATHETER received FDA 510(k) clearance on 2008-01-16, under 510(k) number K073318.

Who is the listed applicant for BIPORE BALLOON DILATION CATHETER?

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

What is the FDA product code for BIPORE BALLOON DILATION CATHETER?

The FDA product code for BIPORE BALLOON DILATION CATHETER is LIT.

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Other records listing Bipore, 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.

K073434BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERK051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERK041293BIOPORE BALLOON DILATION CATHETERK983650BIPORE BALLOON DILATATION CATHETERK973563BIPORE BALLOON DILATATION CATHETERK964814BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

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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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