Title 21

PART 870 SUBPART B

Subpart B - Cardiovascular Diagnostic Devices

• 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
• 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

21:8.0.1.1.22.2.1.1	SECTION 870.1025	870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
21:8.0.1.1.22.2.1.2	SECTION 870.1100	870.1100 Blood pressure alarm.
21:8.0.1.1.22.2.1.3	SECTION 870.1110	870.1110 Blood pressure computer.
21:8.0.1.1.22.2.1.4	SECTION 870.1120	870.1120 Blood pressure cuff.
21:8.0.1.1.22.2.1.5	SECTION 870.1130	870.1130 Noninvasive blood pressure measurement system.
21:8.0.1.1.22.2.1.6	SECTION 870.1140	870.1140 Venous blood pressure manometer.
21:8.0.1.1.22.2.1.7	SECTION 870.1200	870.1200 Diagnostic intravascular catheter.
21:8.0.1.1.22.2.1.8	SECTION 870.1210	870.1210 Continuous flush catheter.
21:8.0.1.1.22.2.1.9	SECTION 870.1220	870.1220 Electrode recording catheter or electrode recording probe.
21:8.0.1.1.22.2.1.10	SECTION 870.1230	870.1230 Fiberoptic oximeter catheter.
21:8.0.1.1.22.2.1.11	SECTION 870.1240	870.1240 Flow-directed catheter.
21:8.0.1.1.22.2.1.12	SECTION 870.1250	870.1250 Percutaneous catheter.
21:8.0.1.1.22.2.1.13	SECTION 870.1251	870.1251 Temporary catheter for embolic protection during transcatheter intracardiac procedures.
21:8.0.1.1.22.2.1.14	SECTION 870.1255	870.1255 Balloon aortic valvuloplasty catheter.
21:8.0.1.1.22.2.1.15	SECTION 870.1270	870.1270 Intracavitary phonocatheter system.
21:8.0.1.1.22.2.1.16	SECTION 870.1280	870.1280 Steerable catheter.
21:8.0.1.1.22.2.1.17	SECTION 870.1290	870.1290 Steerable catheter control system.
21:8.0.1.1.22.2.1.18	SECTION 870.1300	870.1300 Catheter cannula.
21:8.0.1.1.22.2.1.19	SECTION 870.1310	870.1310 Vessel dilator for percutaneous catheterization.
21:8.0.1.1.22.2.1.20	SECTION 870.1330	870.1330 Catheter guide wire.
21:8.0.1.1.22.2.1.21	SECTION 870.1340	870.1340 Catheter introducer.
21:8.0.1.1.22.2.1.22	SECTION 870.1350	870.1350 Catheter balloon repair kit.
21:8.0.1.1.22.2.1.23	SECTION 870.1360	870.1360 Trace microsphere.
21:8.0.1.1.22.2.1.24	SECTION 870.1370	870.1370 Catheter tip occluder.
21:8.0.1.1.22.2.1.25	SECTION 870.1380	870.1380 Catheter stylet.
21:8.0.1.1.22.2.1.26	SECTION 870.1390	870.1390 Trocar.
21:8.0.1.1.22.2.1.27	SECTION 870.1415	870.1415 Coronary vascular physiologic simulation software device.
21:8.0.1.1.22.2.1.28	SECTION 870.1425	870.1425 Programmable diagnostic computer.
21:8.0.1.1.22.2.1.29	SECTION 870.1435	870.1435 Single-function, preprogrammed diagnostic computer.
21:8.0.1.1.22.2.1.30	SECTION 870.1450	870.1450 Densitometer.
21:8.0.1.1.22.2.1.31	SECTION 870.1650	870.1650 Angiographic injector and syringe.
21:8.0.1.1.22.2.1.32	SECTION 870.1660	870.1660 Indicator injector.
21:8.0.1.1.22.2.1.33	SECTION 870.1670	870.1670 Syringe actuator for an injector.
21:8.0.1.1.22.2.1.34	SECTION 870.1750	870.1750 External programmable pacemaker pulse generator.
21:8.0.1.1.22.2.1.35	SECTION 870.1800	870.1800 Withdrawal-infusion pump.
21:8.0.1.1.22.2.1.36	SECTION 870.1875	870.1875 Stethoscope.
21:8.0.1.1.22.2.1.37	SECTION 870.1915	870.1915 Thermodilution probe.

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