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FDA 510(k)

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

K-Number: K252533 · 2025-12-18

ApplicantEdwards Lifesciences
Decision Date2025-12-18
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2025-12-18 under approval number K252533. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is a medical device that received FDA 510(k) clearance on 2025-12-18. It is manufactured by Edwards Lifesciences. The 510(k) number is K252533.

When was HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) approved by the FDA?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) received FDA 510(k) clearance on 2025-12-18, under approval number K252533.

What company makes HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is manufactured by Edwards Lifesciences.

What is the FDA product code for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

The FDA product code for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is DQK.

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Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025)

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K153069Edwards Balloon Catheter 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

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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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