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510(k) K900379

HYCULT DIAMOND CORONARY BYPASS KNIFE by St. Jude Medical, Inc. — Product Code DWS

K900379 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Inc. for the device "HYCULT DIAMOND CORONARY BYPASS KNIFE". The FDA issued a decision of Substantially Equivalent on March 19, 1990. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. St. Jude Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1990
Date Received
January 26, 1990
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 St. Jude Medical, Inc.

  • K172393 — Advisor HD Grid Mapping Catheter, Sensor Enabled (April 23, 2018)
  • K163407 — Confirm Rx Insertable Cardiac Monitor (ICM) System (September 29, 2017)
  • K161171 — PressureWire X Guidewire (August 15, 2016)
  • K161102 — Nanostim Introducer Kit (May 19, 2016)
  • K160716 — The Nanostim Introducer Kit (April 14, 2016)
  • K140793 — NANOSTIM INTRODUCER KIT (December 17, 2014)
  • K133481 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (May 28, 2014)
  • K131592 — ENLIGHTN RENAL GUIDE CATHETER (January 31, 2014)
  • K073700 — 6F PROXIS SYSTEM (October 2, 2008)
  • K042734 — SJM RIGID SADDLE RING MODEL RSAR-(SIZE) (December 17, 2004)

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)
  • K896307 — INSULATION PAD (January 19, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)

FDA data resources