The following data is part of a premarket notification filed by Asset Medikal Tasarim A.s. with the FDA for Flowart.
Device ID | K190806 |
510k Number | K190806 |
Device Name: | Flowart |
Classification | Set, Administration, Intravascular |
Applicant | ASSET MEDIKAL TASARIM A.S. Marmara San. Sit. M Blok No: 7-A, Ikitelli Kucukcekmece Istanbul, TR 34303 |
Contact | Ebru Sirali |
Correspondent | Raymond Kelly Licensale Inc 3422 Leonardo Lane New Myrna 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 | 2019-03-29 |
Decision Date | 2020-02-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
28699443585418 | K190806 | 000 |
28699443580109 | K190806 | 000 |
28699443585067 | K190806 | 000 |
28699443585074 | K190806 | 000 |
28699443580017 | K190806 | 000 |
28699443580352 | K190806 | 000 |
28699443583490 | K190806 | 000 |
28699443583513 | K190806 | 000 |
28699443584213 | K190806 | 000 |
28699443585371 | K190806 | 000 |
28699443585388 | K190806 | 000 |
28699443585395 | K190806 | 000 |
28699443585401 | K190806 | 000 |
08699443580075 | K190806 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLOWART 98539215 not registered Live/Pending |
FlowArt Therapy, PLLC 2024-05-08 |
FLOWART 98119569 not registered Live/Pending |
Lifelines, LLC 2023-08-07 |
FLOWART 98107631 not registered Live/Pending |
FLXON Incorporated 2023-07-28 |
FLOWART 98032920 not registered Live/Pending |
Asset Medical International, Inc. 2023-06-08 |