FDA 510(k)

MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER

K-Number: K933011 · 1994-02-01

Decision Date1994-02-01

Product CodeEZN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1994-02-01 under 510(k) number K933011. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER?

MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER is a medical device that received FDA 510(k) clearance on 1994-02-01. The listed applicant is Boston Scientific Corp. The 510(k) number is K933011.

When did MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER receive FDA 510(k) clearance?

MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER received FDA 510(k) clearance on 1994-02-01, under 510(k) number K933011.

Who is the listed applicant for MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER?

The FDA product code for MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER is EZN.

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 Boston Scientific Corp as applicant

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS K133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM K131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES K131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 devices →

Related Devices (Code: EZN)

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated K180756Safety Wire Guide IntroducerCook Incorporated

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.