Medical Device Manufacturer · US , Carlsbad , CA

Cardiotronics Systems, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiotronics Systems, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared May 15, 1997

700-SP SERIES DISPOSABLE STIMULATION ELECTRODES

Cardiovascular · 48d

Cleared Apr 16, 1997

700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES

Cardiovascular · 48d

Cleared Jan 15, 1997

700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES

Cardiovascular · 33d

Cleared Dec 11, 1996

700-F SERIES STIMULATION ELECTRODES

Cardiovascular · 34d