510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020701Substantially Equivalent

Syncrus Internal Cardioversion System

Guidant Corporation, Cardiac Surgery, Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020701 is the FDA 510(k) clearance record for SYNCRUS INTERNAL CARDIOVERSION SYSTEM, a class II device, cleared for Guidant Corporation, Cardiac Surgery on under FDA product code NHW (Electrode, Pacing And Cardioversion, Temporary, Epicardial). FDA's definition for product code NHW reads: "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". FDA records list 8 510(k) clearances for Guidant Corporation, Cardiac Surgery, from to . As of , FDA records show no recalls naming K020701.

Clearance record

Decision date
Received
(81 days to decision)
Product code
NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidant Corporation, Cardiac Surgery 3200 Lakeside Dr., Santa Clara CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHW

Trailing 12 months

FDA records hold no clearances under product code NHW in the trailing twelve months.

FDA records show no clearances under product code NHW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NHW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260