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510(k) K944858

BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS by Baxter Edwards — Product Code DSY

K944858 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS". The FDA issued a decision of ST on January 5, 1995. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Baxter Edwards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
January 5, 1995
Date Received
October 3, 1994
Clearance Type
Traditional
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 Baxter Edwards

  • K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND P (May 4, 2000)
  • K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS (November 24, 1998)
  • K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4 (July 7, 1998)
  • K965137 — FOGARTY VALVULOTOME MODEL 700091 (June 4, 1997)
  • K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (March 27, 1997)
  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
  • K940795 — SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER (May 24, 1994)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

Other clearances for product code DSY

  • K252445 — Fusion Bioline Vascular Graft (April 27, 2026)
  • 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)

FDA data resources