Q2 Multiport IV Administration Sets And Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

Set, Administration, Intravascular

QUEST MEDICAL, INC.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Q2 Multiport Iv Administration Sets And Extension Sets, Checkmate Multiport Iv Administration Sets, Q2 Extension Sets.

Pre-market Notification Details

• Device ID: K162304
• 510k Number: K162304
• Device Name: Q2 Multiport IV Administration Sets And Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
• Classification: Set, Administration, Intravascular
• Applicant: QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY Allen, TX 75002
• Contact: Amy Clendening-wheeler
• Correspondent: Amy Clendening-wheeler; QUEST MEDICAL, INC. ONE ALLENTOWN PARKWAY Allen, TX 75002
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-17
• Decision Date: 2016-12-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20634624954803	K162304	000
20634624921119	K162304	000
00634624911031	K162304	000
20634624952014	K162304	000
20634624957866	K162304	000
20634624957910	K162304	000
00634624901018	K162304	000
00634624901025	K162304	000
20634624901036	K162304	000
20634624957705	K162304	000
00634624957787	K162304	000
00634624957794	K162304	000
20634624957828	K162304	000
00634624957886	K162304	000
20634624957897	K162304	000
20634624957248	K162304	000
00634624957817	K162304	000
00634624957879	K162304	000
00634624921122	K162304	000