The following data is part of a premarket notification filed by Dragon Heart Medical Devices Co., Ltd. with the FDA for Dragon Heart I.v. Set.
| Device ID | K043235 |
| 510k Number | K043235 |
| Device Name: | DRAGON HEART I.V. SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst, IL 60126 |
| Contact | Jina Yu |
| Correspondent | Jina Yu DRAGON HEART MEDICAL DEVICES CO., LTD. 188 INDUSTRIAL DRIVE SUITE 108 Elmhurst, IL 60126 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2005-03-08 |