Data / Medical devices / United States / Dragon Heart Medical, Inc.
Dragon Heart Medical, Inc.: FDA-registered device maker in Elmhurst, IL, United States, 2 510(k) clearances
Dragon Heart Medical, Inc. is registered with the FDA (registration 3004735647) in Elmhurst, IL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 18, 2010. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004735647
- Address
- 643 N York St Ste 29, Elmhurst, IL, United States, 60126
- Owner or operator
- DRAGON HEART MEDICAL, INC. (9065823)
- Roles
- Specification developer
- First device listed
- December 8, 2010
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 18, 2010 | K101368 | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES | FPA | Substantially Equivalent | Dragon Heart Medical, Inc. | accessdata.fda.gov |
| March 8, 2005 | K043235 | DRAGON HEART I.V. SET | FPA | Substantially Equivalent | Dragon Heart Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 18, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.