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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

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.

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  • 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)

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