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21 C.F.R. § 870.1240   Flow-directed catheter.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices

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§ 870.1240   Flow-directed catheter.

(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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