Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K122544 |
Device Name |
TERUMO SURFLASH SAFETY I.V. CATHETER |
Applicant |
TERUMO Corporation |
1727-1, TSUIJIARAI, SHOWA-CHO |
NAKAKOMA-GUN |
YAMANASHI,
JP
409-3853
|
|
Applicant Contact |
SANDI HARTKA |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 09/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|