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FDA 510(k)

CATHETER, CARDIOVASCULAR, BALLOON TYPE

K-Number: K883852 · 1989-12-07

ApplicantWb Intl., Inc.
Decision Date1989-12-07
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, CARDIOVASCULAR, BALLOON TYPE is the device name listed in this FDA 510(k) record. The listed applicant is Wb Intl., Inc.. It received FDA 510(k) clearance on 1989-12-07 under 510(k) number K883852. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, CARDIOVASCULAR, BALLOON TYPE?

CATHETER, CARDIOVASCULAR, BALLOON TYPE is a medical device that received FDA 510(k) clearance on 1989-12-07. The listed applicant is Wb Intl., Inc.. The 510(k) number is K883852.

When did CATHETER, CARDIOVASCULAR, BALLOON TYPE receive FDA 510(k) clearance?

CATHETER, CARDIOVASCULAR, BALLOON TYPE received FDA 510(k) clearance on 1989-12-07, under 510(k) number K883852.

Who is the listed applicant for CATHETER, CARDIOVASCULAR, BALLOON TYPE?

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

What is the FDA product code for CATHETER, CARDIOVASCULAR, BALLOON TYPE?

The FDA product code for CATHETER, CARDIOVASCULAR, BALLOON TYPE is DXE.

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 Wb Intl., 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.

K885089SURGICAL GLOVES

Related Devices (Code: DXE)

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.

K240078Fogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLCK241330Fogarty Fortis Arterial Embolectomy CatheterEdwards LifesciencesK233820Fogarty Arterial Embolectomy Catheter with Gate ValveEdwards LifesciencesK233819Fogarty Venous Thrombectomy CathetersEdwards Lifesciences, LLCK233619Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersEdwards LifesciencesK213771Merlin Aspiration SystemMivi Neurovascular, 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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