Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K871132 |
Device Name |
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS |
Applicant |
DELTEC SYSTEMS, INC. |
1265 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Applicant Contact |
W NUMAINVILLE |
Correspondent |
DELTEC SYSTEMS, INC. |
1265 GREY FOX RD. |
ST PAUL,
MN
55112
|
|
Correspondent Contact |
W NUMAINVILLE |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/20/1987 |
Decision Date | 04/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|