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FDA 510(k)

XTRA Collection sets; XTRA Sequestration set X

K-Number: K241236 · 2024-08-16

ApplicantSorin Group Italia S.R.L.
Decision Date2024-08-16
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XTRA Collection sets; XTRA Sequestration set X is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-08-16 under approval number K241236. 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 Collection sets; XTRA Sequestration set X?

XTRA Collection sets; XTRA Sequestration set X is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K241236.

When was XTRA Collection sets; XTRA Sequestration set X approved by the FDA?

XTRA Collection sets; XTRA Sequestration set X received FDA 510(k) clearance on 2024-08-16, under approval number K241236.

What company makes XTRA Collection sets; XTRA Sequestration set X?

XTRA Collection sets; XTRA Sequestration set X is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for XTRA Collection sets; XTRA Sequestration set X?

The FDA product code for XTRA Collection sets; XTRA Sequestration set X is CAC.

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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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