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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 870 - Cardiovascular Devices |
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Subpart B - Cardiovascular Diagnostic Devices |
| § 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. |
| § 870.1250 - Percutaneous catheter. |
| § 870.1251 - Temporary catheter for embolic protection during transcatheter intracardiac procedures. |
| § 870.1252 - Percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access. |
| § 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. |
| § 870.1342 - Reverse central venous recanalization system. |
| § 870.1345 - Intravascular bleed monitor. |
| § 870.1350 - Catheter balloon repair kit. |
| § 870.1360 - Trace microsphere. |
| § 870.1370 - Catheter tip occluder. |
| § 870.1380 - Catheter stylet. |
| § 870.1390 - Trocar. |
| § 870.1405 - Interventional cardiovascular implant simulation software device. |
| § 870.1415 - Coronary vascular physiologic simulation software device. |
| § 870.1420 - Coronary artery disease risk indicator using acoustic heart signals. |
| § 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. |
| § 870.1670 - Syringe actuator for an injector. |
| § 870.1750 - External programmable pacemaker pulse generator. |
| § 870.1800 - Withdrawal-infusion pump. |
| § 870.1875 - Stethoscope. |
| § 870.1915 - Thermodilution probe. |