HEPARIN LOCK / FLUSH SYRINGES

Heparin, Vascular Access Flush

Excelsior Medical Corporation

The following data is part of a premarket notification filed by Excelsior Medical Corporation with the FDA for Heparin Lock / Flush Syringes.

Pre-market Notification Details

• Device ID: K133446
• 510k Number: K133446
• Device Name: HEPARIN LOCK / FLUSH SYRINGES
• Classification: Heparin, Vascular Access Flush
• Applicant: Excelsior Medical Corporation 1933 HECK AVE Neptune, NJ 07753
• Contact: John Linfante
• Correspondent: John Linfante; Excelsior Medical Corporation 1933 HECK AVE Neptune, NJ 07753
• Product Code: NZW
• CFR Regulation Number: 880.5200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-11-12
• Decision Date: 2014-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10363807600055	K133446	000
10888277675919	K133446	000
30888277675890	K133446	000
30888277675906	K133446	000
20363807500512	K133446	000
20363807500550	K133446	000
20363807600519	K133446	000
20363807600557	K133446	000
40363807600513	K133446	000
10363807500058	K133446	000
00363807600515	K133446	000