FDA 510(k)

MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL

K-Number: K010730 · 2001-05-16

Decision Date2001-05-16

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL is the device name listed in this FDA 510(k) record. The listed applicant is Usa Instruments, Inc.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K010730. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL?

MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Usa Instruments, Inc.. The 510(k) number is K010730.

When did MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL receive FDA 510(k) clearance?

MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL received FDA 510(k) clearance on 2001-05-16, under 510(k) number K010730.

Who is the listed applicant for MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL?

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

What is the FDA product code for MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL?

The FDA product code for MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL is MOS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Usa Instruments, Inc. as applicant

K052916USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY K0525841.5T 12 CHANNEL BODY ARRAY K0526211.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL K0525853T HD BREAST ARRAY K050728OPEN BREAST COIL (OBC) WITH BIOPSY PLATES K042342MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL

View all 64 devices →

Related Devices (Code: MOS)

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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.