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FDA 510(k)

XTRA Autotransfusion System (with XTRA Bowl sets)

K-Number: K240584 · 2024-04-29

ApplicantSorin Group Italia S.R.L.
Decision Date2024-04-29
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XTRA Autotransfusion System (with XTRA Bowl sets) is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K240584. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTRA Autotransfusion System (with XTRA Bowl sets)?

XTRA Autotransfusion System (with XTRA Bowl sets) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K240584.

When did XTRA Autotransfusion System (with XTRA Bowl sets) receive FDA 510(k) clearance?

XTRA Autotransfusion System (with XTRA Bowl sets) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K240584.

Who is the listed applicant for XTRA Autotransfusion System (with XTRA Bowl sets)?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets)?

The FDA product code for XTRA Autotransfusion System (with XTRA Bowl sets) is CAC.

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics CorporationK201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation

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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