Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K983861 |
Device Name |
DISTAFLO BYPASS GRAFT |
Applicant |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Applicant Contact |
KRISTI M KISTNER |
Correspondent |
IMPRA, INC. |
1625 WEST 3RD ST. |
P.O. BOX 1740 |
TEMPE,
AZ
85281
|
|
Correspondent Contact |
KRISTI M KISTNER |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 11/02/1998 |
Decision Date | 11/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|