The following data is part of a premarket notification filed by Dragon Heart Medical, Inc. with the FDA for D. Heart Medical Intravascular Administration Set, Safety Acces Device And Accessories.
| Device ID | K101368 |
| 510k Number | K101368 |
| Device Name: | D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES |
| Classification | Set, Administration, Intravascular |
| Applicant | DRAGON HEART MEDICAL, INC. 205 W GRAND AVE SUITE 105 Bensenville, IL |
| Contact | Jina Yu |
| Correspondent | Jina Yu DRAGON HEART MEDICAL, INC. 205 W GRAND AVE SUITE 105 Bensenville, IL |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2010-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38498840012698 | K101368 | 000 |
| 38498840012827 | K101368 | 000 |
| 38498840012810 | K101368 | 000 |
| 38498840012797 | K101368 | 000 |
| 38498840012728 | K101368 | 000 |
| 30849884003278 | K101368 | 000 |
| 30849884002783 | K101368 | 000 |
| 30849884002158 | K101368 | 000 |
| 30849884001700 | K101368 | 000 |
| 30849884001564 | K101368 | 000 |
| 30849884001533 | K101368 | 000 |
| 30849884001410 | K101368 | 000 |
| 30849884003735 | K101368 | 000 |
| 30849884003704 | K101368 | 000 |
| 38498840012865 | K101368 | 000 |
| 38498840012872 | K101368 | 000 |
| 38498840012681 | K101368 | 000 |
| 38498840012674 | K101368 | 000 |
| 38498840012667 | K101368 | 000 |
| 38498840012650 | K101368 | 000 |
| 38498840012643 | K101368 | 000 |
| 38498840012636 | K101368 | 000 |
| 38498840012988 | K101368 | 000 |
| 38498840012971 | K101368 | 000 |
| 38498840012940 | K101368 | 000 |
| 38498840012933 | K101368 | 000 |
| 38498840012902 | K101368 | 000 |
| 38498840012896 | K101368 | 000 |
| 38498840012889 | K101368 | 000 |
| 30849884001229 | K101368 | 000 |