CARDIOCEL

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

CELXCEL PTY LTD

The following data is part of a premarket notification filed by Celxcel Pty Ltd with the FDA for Cardiocel.

Pre-market Notification Details

• Device ID: K130872
• 510k Number: K130872
• Device Name: CARDIOCEL
• Classification: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
• Applicant: CELXCEL PTY LTD 1801 ROCKVILLE PIKE, SUITE 300 Rockville, MD 20852
• Contact: Christopher Sloan
• Correspondent: Christopher Sloan; CELXCEL PTY LTD 1801 ROCKVILLE PIKE, SUITE 300 Rockville, MD 20852
• Product Code: DXZ
• CFR Regulation Number: 870.3470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-29
• Decision Date: 2014-01-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09348992000495	K130872	000
09348992000143	K130872	000
09348992000105	K130872	000
09348992000082	K130872	000
09348992000037	K130872	000
09348992000020	K130872	000
09348992000013	K130872	000
09348992000006	K130872	000
00840663110544	K130872	000
00840663110773	K130872	000
00840663110674	K130872	000
00840663110667	K130872	000
00840663110605	K130872	000
00840663110575	K130872	000
00840663110568	K130872	000
09348992000150	K130872	000
09348992000181	K130872	000
09348992000198	K130872	000
09348992000488	K130872	000
09348992000457	K130872	000
09348992000440	K130872	000
09348992000402	K130872	000
09348992000372	K130872	000
09348992000365	K130872	000
09348992000631	K130872	000
09348992000624	K130872	000
09348992000617	K130872	000
09348992000600	K130872	000
09348992000587	K130872	000
09348992000594	K130872	000
09348992000235	K130872	000
09348992000228	K130872	000
00840663110551	K130872	000