Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K210037 |
Device Name |
Pluski Safe 1 Safety IV Catheter |
Applicant |
Mediplus (India) Limited |
1261-1262, M.I.E. Part B, Bahadurgarh-124507 Haryana (India) |
Bahadurgarh,
IN
124507
|
|
Applicant Contact |
Alka Goel |
Correspondent |
Mediplus (India) Limited |
1261-1262, M.I.E. Part B, Bahadurgarh-124507 Haryana (India) |
Bahadurgarh,
IN
124507
|
|
Correspondent Contact |
Alka Goel |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 01/06/2021 |
Decision Date | 03/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|