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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 3-55: ASTM F1830-97 (Reapproved 2013), standard practice for selection of blood for in vitro evaluation of blood pumps. (Cardiovascular)

Date of Standard: 1997. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Continuous Flow Blood Pumps for Short Term (<=6HRS) Durations of Use
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Vertical
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§870.4360 Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class 3 KFM
§870.4370 Pump, Blood, Cardiopulmonary Bypass, Roller Type Class 2 DWB
FDA Technical Contacts:
 Jean E. Rinaldi
  FDA/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 2220
  Silver Spring MD 20993
  301/796-2523
  email: jean.rinaldi@fda.hhs.gov
 Richard A. Malinauskas
  FDA/CDRH/OSEL
  WO62, Room 2108 10903 New Hampshire Avenue
  Silver Spring MD 20993
  301/796-2506
  email: richard.malinauskas.fda.hhs.gov
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