Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K043580 |
Device Name |
ALLIGATOR RETRIEVAL DEVICE (ARD) |
Applicant |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
3583 ROSS ROAD |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
ANNA LONGWELL |
Correspondent |
KEMA QUALITY B.V. |
4377 COUNTY LINE ROAD |
CHALFONT,
PA
18914
|
|
Correspondent Contact |
PATRICIA MURPHY |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/28/2004 |
Decision Date | 03/24/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|