VALVULOTOME (DETACHABLE TYPE)
VALVULOTOME (DETACHABLE TYPE) - C-0104B
Device Description
A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: DWX
Device Name: Stripper, Artery, Intraluminal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4875
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 14953170047692
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170047695
Package Quantity: 1
Package Discontinue Date: 8/15/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 04953170047695
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A