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510(k) K020701

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

K020701 is an FDA 510(k) premarket notification submitted by Guidant Corporation, Cardiac Surgery for the device "SYNCRUS INTERNAL CARDIOVERSION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 2002. 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
May 24, 2002
Date Received
March 4, 2002
Clearance Type
Traditional
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)
  • K024071 — GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (February 14, 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)
  • K020143 — VASOVIEW 5 HARVESTING CANNULA (February 20, 2002)

Other clearances for product code NHW

  • K024071 — GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM (February 14, 2003)

FDA data resources