Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIPORE BALLOON DILATATION CATHETER

K-Number: K961980 · 1996-09-12

ApplicantBipore, Inc.
Decision Date1996-09-12
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 1996-09-12 under 510(k) number K961980. 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 1996-09-12. The listed applicant is Bipore, Inc.. The 510(k) number is K961980.

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

BIPORE BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1996-09-12, under 510(k) number K961980.

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.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CATHETERK973563BIPORE BALLOON DILATATION CATHETER

View all 10 devices →

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.

↑