Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K002962 |
Device Name |
PRESSURE WIRE SENSOR, MODEL 12003/12303 |
Applicant |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Applicant Contact |
MATS GRANLUND |
Correspondent |
RADI MEDICAL SYSTEMS AB |
PALMBLADSGATAN 10 |
UPPSALA,
SE
S-754 50
|
|
Correspondent Contact |
MATS GRANLUND |
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 09/22/2000 |
Decision Date | 10/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|