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510(k) K024071

GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM by Guidant Corporation, Cardiac Surgery — Product Code NHW

K024071 is an FDA 510(k) premarket notification submitted by Guidant Corporation, Cardiac Surgery for the device "GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 14, 2003. The device falls under product code NHW (Electrode, Pacing And Cardioversion, Temporary, Epicardial), a Class II device regulated under 21 CFR 870.3680. Guidant Corporation, Cardiac Surgery has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2003
Date Received
December 10, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacing And Cardioversion, Temporary, Epicardial
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type

The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.

Other clearances by Guidant Corporation, Cardiac Surgery

  • K080169 — HEARTSTRING III PROXIMAL SEAL SYSTEM (February 8, 2008)
  • K041340 — GUIDANT MICROWAVE ABLATION SYSTEM (July 28, 2004)
  • K023630 — ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 (February 20, 2003)
  • K023629 — ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 (November 12, 2002)
  • K022718 — VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 (August 28, 2002)
  • K020701 — SYNCRUS INTERNAL CARDIOVERSION SYSTEM (May 24, 2002)
  • K020143 — VASOVIEW 5 HARVESTING CANNULA (February 20, 2002)

Other clearances for product code NHW

  • K020701 — SYNCRUS INTERNAL CARDIOVERSION SYSTEM (May 24, 2002)

FDA data resources