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FDA 510(k)

BIOPORE BALLOON DILATION CATHETER

K-Number: K041293 · 2004-07-09

ApplicantBipore, Inc.
Decision Date2004-07-09
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOPORE 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 2004-07-09 under 510(k) number K041293. 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 BIOPORE BALLOON DILATION CATHETER?

BIOPORE BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 2004-07-09. The listed applicant is Bipore, Inc.. The 510(k) number is K041293.

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

BIOPORE BALLOON DILATION CATHETER received FDA 510(k) clearance on 2004-07-09, under 510(k) number K041293.

Who is the listed applicant for BIOPORE 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 BIOPORE BALLOON DILATION CATHETER?

The FDA product code for BIOPORE 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 INTRODUCERK073318BIPORE BALLOON DILATION CATHETERK051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERK983650BIPORE 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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