Imed Technology Intravascular Administration Set, Imed Technology Extension Set

Set, Administration, Intravascular

IMED TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Imed Technology, Inc. with the FDA for Imed Technology Intravascular Administration Set, Imed Technology Extension Set.

Pre-market Notification Details

• Device ID: K150513
• 510k Number: K150513
• Device Name: Imed Technology Intravascular Administration Set, Imed Technology Extension Set
• Classification: Set, Administration, Intravascular
• Applicant: IMED TECHNOLOGY, INC. 2544 TARPLEY RD. STE 112 Carrollton, TX 75006
• Contact: Kyle Adams
• Correspondent: Kyle Adams; IMED TECHNOLOGY, INC. 2544 TARPLEY RD. STE 112 Carrollton, TX 75006
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-02-27
• Decision Date: 2015-05-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850048235076	K150513	000
00850048235144	K150513	000
00850048235083	K150513	000
00810094576592	K150513	000
00850048235090	K150513	000
00850048235106	K150513	000
30850048235060	K150513	000
30850048235077	K150513	000
00850048235069	K150513	000
10850048235066	K150513	000
10850048235073	K150513	000
20850048235063	K150513	000
20850048235070	K150513	000
00850048235137	K150513	000