Atlas FDA

XTRA Collection sets; XTRA Sequestration set X

FDA 510(k) clearance K241236 · decided 2024-08-16

Clearance details

K-number
K241236
Device name
XTRA Collection sets; XTRA Sequestration set X
Applicant
Sorin Group Italia S.R.L.
Decision
Substantially Equivalent
Date received
2024-05-02
Decision date
2024-08-16
Days to decision
106 days
Clearance type
Special
Product code
CAC
Device class
2
Regulation number
868.5830
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mirandola ( Modena), IT
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.