The following data is part of a premarket notification filed by Asset Medikal Tasarim As. with the FDA for Neutrart.
| Device ID | K201872 |
| 510k Number | K201872 |
| Device Name: | NeutrArt |
| Classification | Set, Administration, Intravascular |
| Applicant | Asset Medikal Tasarim AS. Ikitelli OSB Mahallesi, 17. Cadde, No: 17 Istanbul, TR 34490 |
| Contact | Ebru Sirali |
| Correspondent | Raymond Kelly Licensale Inc 3422 Leonardo Ln New Smyrna Beach, FL 32168 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-07 |
| Decision Date | 2021-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28699443581212 | K201872 | 000 |
| 28699443585470 | K201872 | 000 |
| 28699443585463 | K201872 | 000 |
| 28699443585456 | K201872 | 000 |
| 28699443585449 | K201872 | 000 |
| 08699443585438 | K201872 | 000 |
| 08699443585421 | K201872 | 000 |
| 28699443581557 | K201872 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NEUTRART 98094162 not registered Live/Pending |
Asset Medical International, Inc. 2023-07-20 |
![]() NEUTRART 79310867 not registered Live/Pending |
ASSET MEDIKAL TASARIM SANAYI VE TICARETANONIM SIRKETI 2021-01-26 |