Flowart

Set, Administration, Intravascular

ASSET MEDIKAL TASARIM A.S.

The following data is part of a premarket notification filed by Asset Medikal Tasarim A.s. with the FDA for Flowart.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
28699443585418	K190806	000
08699443581348	K190806	000
08699443580075	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
28699443581311	K190806	000