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FDA 510(k)

Edwards Balloon Catheter

K-Number: K153069 · 2016-01-07

ApplicantEdwards Lifesciences
Decision Date2016-01-07
Product CodeOMZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards Balloon Catheter is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2016-01-07 under approval number K153069. The device is classified under product code OMZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards Balloon Catheter?

Edwards Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by Edwards Lifesciences. The 510(k) number is K153069.

When was Edwards Balloon Catheter approved by the FDA?

Edwards Balloon Catheter received FDA 510(k) clearance on 2016-01-07, under approval number K153069.

What company makes Edwards Balloon Catheter?

Edwards Balloon Catheter is manufactured by Edwards Lifesciences.

What is the FDA product code for Edwards Balloon Catheter?

The FDA product code for Edwards Balloon Catheter is OMZ.

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Other Devices by Edwards Lifesciences

DEN190029Acumen Assisted Fluid Management (AFM) Software Feature K200258Edwards eSheath Introducer Set K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) K240596Cerebral Autoregulation Index (CAI) Algorithm K241330Fogarty Fortis Arterial Embolectomy Catheter K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)

View all 16 devices →

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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