The following data is part of a premarket notification filed by Mediplus (india) Limited with the FDA for Pluski Safe 1 Safety Iv Catheter.
| Device ID | K210037 |
| 510k Number | K210037 |
| Device Name: | Pluski Safe 1 Safety IV Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Mediplus (India) Limited 1261-1262, M.I.E. Part B, Bahadurgarh-124507 Haryana (India) Bahadurgarh, IN 124507 |
| Contact | Alka Goel |
| Correspondent | Alka Goel Mediplus (India) Limited 1261-1262, M.I.E. Part B, Bahadurgarh-124507 Haryana (India) Bahadurgarh, IN 124507 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-06 |
| Decision Date | 2022-03-25 |