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FDA 510(k)

APEX(TM) PROSTATIC BALLOON DILATION CATHETER

K-Number: K913477 · 1991-12-27

ApplicantPeripheral Systems Group
Decision Date1991-12-27
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

APEX(TM) PROSTATIC BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Peripheral Systems Group. It received FDA 510(k) clearance on 1991-12-27 under 510(k) number K913477. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APEX(TM) PROSTATIC BALLOON DILATION CATHETER?

APEX(TM) PROSTATIC BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1991-12-27. The listed applicant is Peripheral Systems Group. The 510(k) number is K913477.

When did APEX(TM) PROSTATIC BALLOON DILATION CATHETER receive FDA 510(k) clearance?

APEX(TM) PROSTATIC BALLOON DILATION CATHETER received FDA 510(k) clearance on 1991-12-27, under 510(k) number K913477.

Who is the listed applicant for APEX(TM) PROSTATIC BALLOON DILATION CATHETER?

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

What is the FDA product code for APEX(TM) PROSTATIC BALLOON DILATION CATHETER?

The FDA product code for APEX(TM) PROSTATIC BALLOON DILATION CATHETER is KOE.

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 Peripheral Systems Group 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.

K940804SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONK934433VANTAGE DIALTAION CATHETERK932777SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETERK931327PSG DIRECTIONAL HYDROPHILIC GUIDE WIREK915554HI-TORQUE SPORT-T(TM) GUIDE WIREK914979EDM(R) INFUSION CATHETER

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Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.

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.

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