Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K003731 |
Device Name |
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE |
Applicant |
THOMAS MEDICAL PRODUCTS, INC. |
65 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
PETER J RAPP |
Correspondent |
THOMAS MEDICAL PRODUCTS, INC. |
65 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
PETER J RAPP |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 12/04/2000 |
Decision Date | 04/10/2001 |
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
|
|
|