Medical Device Manufacturer · US , Mchenry , IL

Waters Assoc., Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1976

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Waters Assoc., Inc. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Oct 31, 1980

7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

Cardiovascular · 24d

Cleared Jun 22, 1979

4F STERILE BALLOON-LESS, CATHETER 913-28

Cardiovascular · 18d

Cleared Jan 29, 1979

CARDIAC COMPUTERS, CO-10 & CO-10R

Cardiovascular · 97d

Cleared Nov 29, 1978

CALIBRATOR, DYNAMIC

Cardiovascular · 56d

Cleared Mar 27, 1978

RECORDER, RE-100P HOT STYLUS STRIP CHART

Cardiovascular · 42d

Cleared Dec 09, 1976

TC-1 CARDIAC OUTPUT COMPUTER

Cardiovascular · 8d