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510(k) K001927

VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME by Thoratec Laboratories Corp. — Product Code DSY

K001927 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME". The FDA issued a decision of Substantially Equivalent on December 18, 2000. 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. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2000
Date Received
June 26, 2000
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 Thoratec Laboratories Corp.

  • K001926 — VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CU (September 22, 2000)
  • K851495 — THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (August 1, 1985)
  • K833714 — RESPIRATORY ASSESSMENT SYSTEM (December 29, 1983)
  • K833265 — RESPIRATORY FLOW MODULE (November 28, 1983)
  • K831557 — INTRAOPERATIVE AUTOTRANSFUSION SYS (August 24, 1983)
  • K823449 — RESPIRATORY GAS ANALYZER (January 5, 1983)
  • K823287 — RESPIRATORY CIRCUIT ADAPTOR (December 9, 1982)
  • K822769 — THORATEC GAS SAMPLING CONNECTOR (October 6, 1982)
  • K780247 — IMPCO DISPOSABLE AORTIC PUNCH (February 27, 1978)

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