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510(k) K851495

THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY by Thoratec Laboratories Corp.

K851495 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on August 1, 1985. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
August 1, 1985
Date Received
April 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Thoratec Laboratories Corp.

  • K001927 — VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASC (December 18, 2000)
  • K001926 — VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CU (September 22, 2000)
  • 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)

FDA data resources