21 C.F.R. § 870.1310 Vessel dilator for percutaneous catheterization.
Title 21 - Food and Drugs
(a) Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart B—Cardiovascular Diagnostic Devices
§ 870.1310 Vessel dilator for percutaneous catheterization.