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FDA 510(k)

BULLETT PERIPHERAL INFUSION CATHETER

K-Number: K931027 · 1994-02-04

ApplicantCardio-Dynamics, Inc.
Decision Date1994-02-04
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BULLETT PERIPHERAL INFUSION 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 1994-02-04 under 510(k) number K931027. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BULLETT PERIPHERAL INFUSION CATHETER?

BULLETT PERIPHERAL INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Cardio-Dynamics, Inc.. The 510(k) number is K931027.

When did BULLETT PERIPHERAL INFUSION CATHETER receive FDA 510(k) clearance?

BULLETT PERIPHERAL INFUSION CATHETER received FDA 510(k) clearance on 1994-02-04, under 510(k) number K931027.

Who is the listed applicant for BULLETT PERIPHERAL INFUSION 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 BULLETT PERIPHERAL INFUSION CATHETER?

The FDA product code for BULLETT PERIPHERAL INFUSION CATHETER is FOZ.

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 CATHETERK945943CVD PERIFLOW(TM) BALLOON DILATATION CATHETERK942150CVD SMALL VESSEL BALLOON DILATION CATHETER

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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