Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

Device Code: 835

Product Code(s): DYF

Device Classification Information

• Device Type ID: 835
• Device Name: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
• Regulation Description: Vascular Graft Prosthesis.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Cardiovascular Devices (DCD); Vascular Surgery Devices Branch (VSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 870.3450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DYF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 3-54 AAMI ANSI ISO 7198:2016 Second Edition
  Cardiovascular Implants And Extracorporeal Systems--Vascular Prostheses--Tubular Vascular Grafts And Vascular Patches
• 3-144 ISO 7198 Second Edition 2016-08-01
  Cardiovascular Implants And Extracorporeal Systems - Vascular Prostheses - Tubular Vascular Grafts And Vascular Patches

Total Product Life Cycle

• Device Type ID: 835
• Device: Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
• Product Code: DYF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Vascular Graft Prosthesis.
• CFR Regulation Number: 870.3450 [🔎]

Device Problems
Torn Material	23
Leak / Splash	10
Adverse Event Without Identified Device Or Use Problem	6
Occlusion Within Device	4
Material Split, Cut Or Torn	3
Device Contamination With Chemical Or Other Material	2
Hole In Material	2
Material Perforation	1
Split	1
Packaging Problem	1
Material Rupture	1
Obstruction Of Flow	1
Compatibility Problem	1
Total Device Problems	56

TPLC Last Update: 2019-04-02 19:42:52