21 C.F.R. § 870.1310

Vessel dilator for percutaneous catheterization.

Last amended: 2016Year: 2026Length: 44 wordsSubsections: 1Official source

Cite as 21 C.F.R. § 870.1310 (2026)

(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).
21 C.F.R. § 870.1310: Vessel dilator for percutaneous catheterization. | Justis AI