FDA 510(k)

FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE

K-Number: K974067 · 1998-02-27

Decision Date1998-02-27

Product CodeQEY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K974067. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE?

FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K974067.

When did FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE receive FDA 510(k) clearance?

FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE received FDA 510(k) clearance on 1998-02-27, under 510(k) number K974067.

Who is the listed applicant for FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE?

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

What is the FDA product code for FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE?

The FDA product code for FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE is QEY.

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 Merit Medical Systems, Inc. as applicant

K261310FlexTract Deflectable-Rotational Dilator Sheath Set K262086PreludeSYNC™ Radial Compression Device K254073StatSeal Disc K251802STAR RF Ablation System K252892SCOUT MD Surgical Guidance System K250853Merit Syringe

View all 159 devices →

Related Devices (Code: QEY)

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

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.