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Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

by Sorin Group Italia S.R.L. FDA registration: Italy 510(k)

510(k) K162215 Product code DWF

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162215 Date16 Jun 2017ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Sorin Group Italia S.R.L.

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K162215 24 fields · synced 22 Oct 2026