The following data is part of a premarket notification filed by Jiangxi Sanxin Medtec Co., Ltd with the FDA for I.v. Catheter.
| Device ID | K142797 |
| 510k Number | K142797 |
| Device Name: | I.V. Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Jiangxi Sanxin Medtec Co., Ltd No. 999, Fushan Road, Xiaolan Economic Development Nanchang, CN 330200 |
| Contact | Bingrong Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-29 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20858835007947 | K142797 | 000 |
| 20858835007930 | K142797 | 000 |
| 20858835007923 | K142797 | 000 |
| 10858835007919 | K142797 | 000 |
| 20858835007060 | K142797 | 000 |
| 10812460028633 | K142797 | 000 |
| 10812460028619 | K142797 | 000 |