1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 870 - CARDIOVASCULAR DEVICES
  6. Subpart B - Cardiovascular Diagnostic Devices
  7. 21 CFR § 870.1240
21 CFR § 870.1240
Flow-directed catheter
June 25, 2020
CFR

(a) Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

(b) Classification. Class II (performance standards).

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§ 870.1230 Fiberoptic oximeter catheter
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§ 870.1255 Balloon aortic valvuloplasty catheter

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