COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

• K Number: K010055
• Device Name: COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
• Manufacturer: COOK VASCULAR, INC.
• Date Cleared: 2001-06-14 ( 157 days)
• Product Code: DRE
• Regulation Number: 870.1310
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(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).