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Intec Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K911840INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETERJune 3, 1991
K903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETEROctober 19, 1990
K900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETEROctober 19, 1990
K903216THE GUIDER CORONARY GUIDING CATHETEROctober 19, 1990
K903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYOctober 16, 1990
K903906PERCUTANEOUS CATHETER INTRODUCER KITSeptember 26, 1990
K900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVEAugust 14, 1990
K901247TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVESJuly 31, 1990
K894925AMCATH URETERAL DILATORS MODELS 7100,7110,7120December 13, 1989
K860941DISPOSABLE HEATED WIRE LOOPS 48 AND 72April 2, 1986
K823271DISPOSABLE ADULT VO. VENTILATOR CIRCUITDecember 22, 1982
K813317DISP. HYPERINFLATION BAG SYSTEMMarch 12, 1982
K810621DISPOSABLE 22MM. FLEXIBLE ADAPTORApril 17, 1981
K810620DISPOSABLE ELBOW ADAPTORMarch 20, 1981
K801261DISPOSABLE COUPLING ADAPTORJune 9, 1980
K801260DISPOSABLE PRESSURE LINE ADAPTORJune 4, 1980
K800562DISPOSABLE HAND HELD NEBULIZERMarch 25, 1980