Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K031920 |
Device Name |
CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 |
Applicant |
TRANS VASCULAR INCORPORATED |
1505-D ADAMS DR. |
MENLO PARK,
CA
94925
|
|
Applicant Contact |
RICHARD E ANDERSON |
Correspondent |
TRANS VASCULAR INCORPORATED |
1505-D ADAMS DR. |
MENLO PARK,
CA
94925
|
|
Correspondent Contact |
RICHARD E ANDERSON |
Regulation Number | 892.1570
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/23/2003 |
Decision Date | 07/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|