Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K093406 |
Device Name |
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 |
Applicant |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Applicant Contact |
JODI LYNN FRASIER |
Correspondent |
ANGIODYNAMICS, INC. |
603 QUEENSBURY AVE. |
QUEENSBURY,
NY
12804
|
|
Correspondent Contact |
JODI LYNN FRASIER |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 11/02/2009 |
Decision Date | 03/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
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
|
|
|