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510(k) K233783

exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts by Peca Labs, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2024
Date Received
November 27, 2023
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 Peca Labs, Inc.

  • K221628 — exGraft, exGraft Carbon (August 4, 2022)
  • K202471 — exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft (December 11, 2020)
  • K183613 — exGraft, exGraft Carbon (April 22, 2019)
  • K180957 — exGraft, exGraft Carbon ePTFE Vascular Grafts (August 21, 2018)

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)
  • 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)
  • K221628 — exGraft, exGraft Carbon (August 4, 2022)