Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION

K-Number: K911581 · 1991-06-04

ApplicantJohnson & Johnson Interventional Systems
Decision Date1991-06-04
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Interventional Systems. It received FDA 510(k) clearance on 1991-06-04 under 510(k) number K911581. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION?

PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-06-04. The listed applicant is Johnson & Johnson Interventional Systems. The 510(k) number is K911581.

When did PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION receive FDA 510(k) clearance?

PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION received FDA 510(k) clearance on 1991-06-04, under 510(k) number K911581.

Who is the listed applicant for PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION?

The FDA 510(k) record lists Johnson & Johnson Interventional Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION?

The FDA product code for PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION is FGE.

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 Johnson & Johnson Interventional Systems 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.

K905720PALMAZ BILIARY STENT

Related Devices (Code: FGE)

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.

K254179Drainage CatheterCanyon Medical, Inc.K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019Hangzhou AGS MedTech Co., Ltd.K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH

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.

↑