Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-55: ASTM F1830-97 (2005), Standard Practice for Selection of Blood for In Vitro Evaluation of Blood Pumps. (Cardiovascular)
Date of Standard: 2005. |
| Address of Standards 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) |
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| Devices Affected: |
| Continuous Flow Blood Pumps for Short Term (<=6HRS) Durations of Use |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Vertical |
| Extent of Recognition: |
Complete Standard
NOTE: In general, this standard provides some basic guidelines for the selection of blood to be used in performing hemolysis testing on blood pumps. |
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| 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 |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.4370 |
Pump, Blood, Cardiopulmonary Bypass, Roller Type |
Class 2 |
DWB |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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 |
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