The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co.,ltd. with the FDA for High Pressure Tubing.
| Device ID | K170014 |
| 510k Number | K170014 |
| Device Name: | High Pressure Tubing |
| Classification | Injector And Syringe, Angiographic |
| Applicant | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Contact | Xu Jianhai |
| Correspondent | Jeffery Hui SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004162118 | K170014 | 000 |
| 40889942862093 | K170014 | 000 |
| 40889942861799 | K170014 | 000 |
| 40889942860938 | K170014 | 000 |
| 40193489896818 | K170014 | 000 |
| 40193489896801 | K170014 | 000 |
| 40193489761833 | K170014 | 000 |
| 40193489761826 | K170014 | 000 |
| 40193489761550 | K170014 | 000 |
| 40193489761543 | K170014 | 000 |
| 26950900942901 | K170014 | 000 |
| 26950900942895 | K170014 | 000 |
| 26950900942888 | K170014 | 000 |
| 26950900926789 | K170014 | 000 |
| 26950900920657 | K170014 | 000 |
| 26950900920640 | K170014 | 000 |
| 26950900920633 | K170014 | 000 |
| 40889942862109 | K170014 | 000 |
| 40889942862116 | K170014 | 000 |
| 00850004162101 | K170014 | 000 |
| 00850004162095 | K170014 | 000 |
| 00850004162088 | K170014 | 000 |
| 00850004162071 | K170014 | 000 |
| 00850004162064 | K170014 | 000 |
| 40889942862758 | K170014 | 000 |
| 40889942862741 | K170014 | 000 |
| 40889942862734 | K170014 | 000 |
| 40889942862727 | K170014 | 000 |
| 40889942862628 | K170014 | 000 |
| 40889942862611 | K170014 | 000 |
| 40889942862574 | K170014 | 000 |
| 40889942862567 | K170014 | 000 |
| 40889942862550 | K170014 | 000 |
| 40889942862130 | K170014 | 000 |
| 40889942862123 | K170014 | 000 |
| 26950900920626 | K170014 | 000 |