Device Classification Name |
apparatus, autotransfusion
|
510(k) Number |
K140205 |
Device Name |
PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM |
Applicant |
Teleflex Medical, Inc. |
2917 WECK DR. |
PO BOX 12600 |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Applicant Contact |
HOLLY KORNEGAY |
Correspondent |
Teleflex Medical, Inc. |
2917 WECK DR. |
PO BOX 12600 |
RESEARCH TRIANGLE PARK,
NC
27709
|
|
Correspondent Contact |
HOLLY KORNEGAY |
Regulation Number | 868.5830
|
Classification Product Code |
|
Date Received | 01/27/2014 |
Decision Date | 10/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|