NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

Suture, Nonabsorbable, Synthetic, Polyethylene

GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Nextstitch Cardiovascular Valve Suture.

Pre-market Notification Details

• Device ID: K001440
• 510k Number: K001440
• Device Name: NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740
• Contact: Mary E Gray
• Correspondent: Mary E Gray; GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 600 AIRPORT RD. Fall River, MA 02720 -4740
• Product Code: GAT
• CFR Regulation Number: 878.5000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-05-08
• Decision Date: 2000-11-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
24026704410983	K001440	000
24026704666373	K001440	000
24026704666366	K001440	000
24026704666359	K001440	000
24026704666342	K001440	000
24026704666335	K001440	000
24026704666328	K001440	000
24026704666311	K001440	000
24026704666304	K001440	000
24026704666298	K001440	000
24026704666380	K001440	000
24026704666397	K001440	000
24026704666403	K001440	000
24026704410976	K001440	000
24026704410921	K001440	000
24026704410914	K001440	000
24026704410907	K001440	000
24026704410891	K001440	000
24026704724912	K001440	000
24026704666434	K001440	000
24026704666427	K001440	000
24026704666410	K001440	000
24026704666281	K001440	000
24026704666274	K001440	000
24026704924008	K001440	000
24026704923995	K001440	000
24026704923988	K001440	000
24026704923971	K001440	000
24026704923964	K001440	000
24026704923957	K001440	000
24026704923940	K001440	000
34026704923930	K001440	000
34026704923923	K001440	000
24026704924015	K001440	000
24026704924022	K001440	000
24026704924046	K001440	000
24026704666267	K001440	000
24026704666250	K001440	000
24026704924121	K001440	000
24026704924114	K001440	000
24026704924107	K001440	000
24026704924091	K001440	000
24026704924084	K001440	000
24026704924077	K001440	000
24026704924053	K001440	000
24026704730418	K001440	000
24026704416497	K001440	000
34026704638902	K001440	000
34026704638728	K001440	000
34026704638711	K001440	000
34026704638704	K001440	000
34026704638698	K001440	000
34026704638674	K001440	000
34026704636168	K001440	000
34026704636151	K001440	000
34026704636144	K001440	000
34026704636137	K001440	000
34026704638735	K001440	000
34026704638742	K001440	000
34026704638759	K001440	000
34026704638896	K001440	000
34026704638889	K001440	000
34026704638872	K001440	000
34026704638827	K001440	000
34026704638810	K001440	000
34026704638803	K001440	000
34026704638780	K001440	000
34026704638773	K001440	000
34026704638766	K001440	000
34026704636120	K001440	000
34026704636113	K001440	000
44026704423604	K001440	000
44026704420498	K001440	000
24026704419252	K001440	000
24026704416602	K001440	000
24026704416596	K001440	000
44026704416583	K001440	000
44026704416545	K001440	000
44026704416521	K001440	000
24026704416510	K001440	000
24026704423617	K001440	000
44026704423635	K001440	000
24026704423648	K001440	000
34026704636106	K001440	000
34026704631880	K001440	000
44026704592317	K001440	000
44026704592133	K001440	000
24026704423822	K001440	000
44026704423802	K001440	000
44026704423734	K001440	000
44026704423727	K001440	000
24026704423655	K001440	000
24026704416503	K001440	000