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510(k) K780247

IMPCO DISPOSABLE AORTIC PUNCH by Thoratec Laboratories Corp. — Product Code DWS

K780247 is an FDA 510(k) premarket notification submitted by Thoratec Laboratories Corp. for the device "IMPCO DISPOSABLE AORTIC PUNCH". The FDA issued a decision of Substantially Equivalent on February 27, 1978. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Thoratec Laboratories Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1978
Date Received
February 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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)
  • 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)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources