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FDA 510(k)

CVD PERIFLOW(TM) BALLOON DILATATION CATHETER

K-Number: K945943 · 1995-02-24

ApplicantCardio-Dynamics, Inc.
Decision Date1995-02-24
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CVD PERIFLOW(TM) BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Dynamics, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K945943. 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 CVD PERIFLOW(TM) BALLOON DILATATION CATHETER?

CVD PERIFLOW(TM) BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Cardio-Dynamics, Inc.. The 510(k) number is K945943.

When did CVD PERIFLOW(TM) BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

CVD PERIFLOW(TM) BALLOON DILATATION CATHETER received FDA 510(k) clearance on 1995-02-24, under 510(k) number K945943.

Who is the listed applicant for CVD PERIFLOW(TM) BALLOON DILATATION CATHETER?

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

What is the FDA product code for CVD PERIFLOW(TM) BALLOON DILATATION CATHETER?

The FDA product code for CVD PERIFLOW(TM) 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 Cardio-Dynamics, 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.

K954313FOCUS PC BALLOON DILATATION CATHETERK942150CVD SMALL VESSEL BALLOON DILATION CATHETERK931027BULLETT PERIPHERAL INFUSION CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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