Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K042126 |
Device Name |
PICC |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE ROAD |
READING,
PA
19612
|
|
Applicant Contact |
SUZANNE SCHORLE |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE ROAD |
READING,
PA
19612
|
|
Correspondent Contact |
SUZANNE SCHORLE |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 08/06/2004 |
Decision Date | 08/27/2004 |
Decision |
SE - With Limitations
(SESU) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|