Home / 510(k) Clearances / K122138

510(k) K122138

ATRIUM FLIXENE IFG VASCULAR GRAFT by Atrium Medical Corp. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2012
Date Received
July 19, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

Other clearances by Atrium Medical Corp.

  • K130131 — EDRAIN CHEST DRAINAGE SYSTEM (February 28, 2013)
  • K121070 — C-QUR RPM MESH (April 26, 2012)
  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K080688 — C-QUR LITE MESH V-PATCH (April 16, 2008)

Other clearances for product code DSY

  • K252277 — Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (October 20, 2025)
  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft (March 28, 2024)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (January 17, 2024)
  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K213845 — HeRO Graft (August 15, 2022)