Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K102008 |
Device Name |
GLIDESHEATH |
Applicant |
TERUMO MEDICAL CORP. |
950 Elkton Blvd. |
Elkton,
MD
21921
|
|
Applicant Contact |
DANIEL R PLONSKI |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 07/16/2010 |
Decision Date | 07/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|