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FDA 510(k)

XTRA

K-Number: K112245 · 2011-09-06

ApplicantSorin Group Italia S.R.L.
Decision Date2011-09-06
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XTRA 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 2011-09-06 under 510(k) number K112245. 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?

XTRA is a medical device that received FDA 510(k) clearance on 2011-09-06. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K112245.

When did XTRA receive FDA 510(k) clearance?

XTRA received FDA 510(k) clearance on 2011-09-06, under 510(k) number K112245.

Who is the listed applicant for XTRA?

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?

The FDA product code for XTRA is CAC.

Related PubMed Literature

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.

PMID: 31116763Identifying extractable profiles from 3D printed medical devices.PloS one ()

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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 MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver 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 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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