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FDA 510(k)

BIPORE BALLOON DILATATION CATHETER

K-Number: K973563 · 1998-04-01

ApplicantBipore, Inc.
Decision Date1998-04-01
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIPORE BALLOON DILATATION 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 1998-04-01 under 510(k) number K973563. 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 DILATATION CATHETER?

BIPORE BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Bipore, Inc.. The 510(k) number is K973563.

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

BIPORE BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1998-04-01, under 510(k) number K973563.

Who is the listed applicant for BIPORE BALLOON DILATATION 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 DILATATION CATHETER?

The FDA product code for BIPORE BALLOON DILATATION 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 INTRODUCERK041293BIOPORE BALLOON DILATION CATHETERK983650BIPORE BALLOON DILATATION CATHETERK964814BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

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Related Devices (Code: LIT)

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.

K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA Balloon CatheterWAVE Medical AGK252512Armada™ 14 NC PTA CatheterABBOTT MEDICALK251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical , Ltd.K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterBiotronik, 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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