7198
Cardiovascular implants - Tubular
3-90 Card
vascular prostheses
First
edition 03/18/2011 ISO
1998-0801
Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-90: ISO 7198 First edition 1998-08-01, Cardiovascular
implants - Tubular vascular prostheses. (Cardiovascular)
Date of Standard: 1998.
Address of Standards Organization:
International Organization for Standardization (ISO)*
1, Rue de Varembe
Case Postale 56
CH 1211 Geneva 20, 0
SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Vascular Graft Prostheses
Processes Affected:
510(k), PMA, IDE, PDP, Design Control Input, Quality System Regulation
Type of Standard:
Vertical
Extent of Recognition:
Complete standard
NOTE: This standard identifies critical parameters for the various types of vascular
prostheses and prescribes test methods. It does not contain acceptance criteria for
the parameters. Additional information as outlined in the Guidance referenced
below must be provided.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name
Device Product
Class
Code
§870.345021 Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class 2 DSY22
§870.345023 Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Class 2 DYF24
Relevant Guidance:
Special Controls for Vascular Prostheses
Draft Guidance for the Preparation of Research and Marketing Applications for
Vascular Graft Protheses (NOTE: The FDA document predates the AAMI standard.
Information covered by AAMI Standard supersedes the FDA document)
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR870.3450]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 870 -- CARDIOVASCULAR DEVICES
Subpart D--Cardiovascular Prosthetic Devices
Sec. 870.3450 Vascular graft prosthesis.
(a)Identification. A vascular graft prosthesis is an implanted
device intended to repair, replace, or bypass sections of native
or artificial vessels, excluding coronary or cerebral vasculature,
and to provide vascular access. It is commonly constructed of
materials such as polyethylene terephthalate and
polytetrafluoroethylene, and it may be coated with a biological
coating, such as albumin or collagen, or a synthetic coating, such
as silicone. The graft structure itself is not made of materials
of animal origin, including human umbilical cords.
(b)Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled
"Guidance Document for Vascular Prostheses 510(k) Submissions."
[66 FR 18542, Apr. 10, 2001]