21 CFR Subpart B
Cardiovascular Diagnostic Devices
June 25, 2020
§
870.1250
Percutaneous catheter
§
870.1251
Temporary catheter for embolic protection during transcatheter intracardiac procedures
§
870.1670
Syringe actuator for an injector
§
870.1750
External programmable pacemaker pulse generator
§
870.1800
Withdrawal-infusion pump
§
870.1025
Arrhythmia detector and alarm (including ST-segment measurement and alarm)
§
870.1100
Blood pressure alarm
§
870.1110
Blood pressure computer
§
870.1120
Blood pressure cuff
§
870.1130
Noninvasive blood pressure measurement system
§
870.1140
Venous blood pressure manometer
§
870.1200
Diagnostic intravascular catheter
§
870.1210
Continuous flush catheter
§
870.1220
Electrode recording catheter or electrode recording probe
§
870.1230
Fiberoptic oximeter catheter
§
870.1240
Flow-directed catheter
§
870.1255
Balloon aortic valvuloplasty catheter
§
870.1270
Intracavitary phonocatheter system
§
870.1280
Steerable catheter
§
870.1290
Steerable catheter control system
§
870.1300
Catheter cannula
§
870.1310
Vessel dilator for percutaneous catheterization
§
870.1330
Catheter guide wire
§
870.1340
Catheter introducer
§
870.1350
Catheter balloon repair kit
§
870.1360
Trace microsphere
§
870.1370
Catheter tip occluder
§
870.1380
Catheter stylet
§
870.1390
Trocar
§
870.1415
Coronary vascular physiologic simulation software device
§
870.1425
Programmable diagnostic computer
§
870.1435
Single-function, preprogrammed diagnostic computer
§
870.1450
Densitometer
§
870.1650
Angiographic injector and syringe
§
870.1660
Indicator injector
§
870.1875
Stethoscope
§
870.1915
Thermodilution probe