Device Classification Name |
introducer, catheter
|
510(k) Number |
K040552 |
Device Name |
MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130 |
Applicant |
CRYOCOR, INC. |
9717 PACIFIC HEIGHTS BLVD. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
JAMI MILLER |
Correspondent |
CRYOCOR, INC. |
9717 PACIFIC HEIGHTS BLVD. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
JAMI MILLER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/02/2004 |
Decision Date | 05/28/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|