The following data is part of a premarket notification filed by Shenzhen Baoan Medical Supplies Co., Ltd with the FDA for Sterile High-pressure Angiographic Syringes For Single-use.
| Device ID | K182289 |
| 510k Number | K182289 |
| Device Name: | Sterile High-pressure Angiographic Syringes For Single-use |
| Classification | Injector And Syringe, Angiographic |
| Applicant | Shenzhen Baoan Medical Supplies Co., Ltd No.6, Shenkeng Road, Shenkeng Industrial Zone Liuyue Community, Henggang Shenzhen, CN 518173 |
| Contact | Mingan Mu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2018-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26938327903224 | K182289 | 000 |
| 26938327906126 | K182289 | 000 |
| 26938327906119 | K182289 | 000 |
| 26938327906102 | K182289 | 000 |
| 26938327906096 | K182289 | 000 |
| 26938327906089 | K182289 | 000 |
| 26938327906041 | K182289 | 000 |
| 26938327906034 | K182289 | 000 |
| 26938327906027 | K182289 | 000 |
| 26938327906010 | K182289 | 000 |
| 16938327906259 | K182289 | 000 |
| 16938327906211 | K182289 | 000 |
| 26938327903002 | K182289 | 000 |
| 26938327903217 | K182289 | 000 |
| 26938327903125 | K182289 | 000 |
| 26938327903118 | K182289 | 000 |
| 26938327903101 | K182289 | 000 |
| 26938327903095 | K182289 | 000 |
| 26938327903088 | K182289 | 000 |
| 26938327903040 | K182289 | 000 |
| 26938327903033 | K182289 | 000 |
| 26938327903026 | K182289 | 000 |
| 26938327903019 | K182289 | 000 |
| 16938327906242 | K182289 | 000 |