LIFESPAN EPTFE VASCULAR GRAFT

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

LEMAITRE VASCULAR, INC.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Lifespan Eptfe Vascular Graft.

Pre-market Notification Details

• Device ID: K130016
• 510k Number: K130016
• Device Name: LIFESPAN EPTFE VASCULAR GRAFT
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Contact: Xiang Zhang
• Correspondent: Xiang Zhang; LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-01
• Decision Date: 2013-02-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840663109494	K130016	000
00840663105311	K130016	000
00840663105328	K130016	000
00840663105335	K130016	000
00840663105342	K130016	000
00840663105359	K130016	000
00840663105366	K130016	000
00840663105373	K130016	000
00840663105380	K130016	000
00840663105397	K130016	000
00840663105403	K130016	000
00840663105410	K130016	000
00840663105427	K130016	000
00840663105434	K130016	000
00840663105441	K130016	000
00840663105458	K130016	000
00840663105465	K130016	000
00840663105304	K130016	000
00840663105298	K130016	000
00840663104888	K130016	000
00840663105137	K130016	000
00840663105144	K130016	000
00840663105151	K130016	000
00840663105168	K130016	000
00840663105175	K130016	000
00840663105182	K130016	000
00840663105199	K130016	000
00840663105205	K130016	000
00840663105229	K130016	000
00840663105236	K130016	000
00840663105243	K130016	000
00840663105250	K130016	000
00840663105267	K130016	000
00840663105274	K130016	000
00840663105281	K130016	000
00840663105472	K130016	000
00840663105489	K130016	000
00840663105670	K130016	000
00840663105687	K130016	000
00840663105694	K130016	000
00840663105700	K130016	000
00840663105717	K130016	000
00840663105724	K130016	000
00840663105731	K130016	000
00840663105748	K130016	000
00840663105755	K130016	000
00840663105762	K130016	000
00840663105779	K130016	000
00840663105786	K130016	000
00840663105793	K130016	000
00840663105809	K130016	000
00840663105816	K130016	000
00840663106790	K130016	000
00840663105663	K130016	000
00840663105656	K130016	000
00840663105496	K130016	000
00840663105502	K130016	000
00840663105519	K130016	000
00840663105526	K130016	000
00840663105533	K130016	000
00840663105540	K130016	000
00840663105557	K130016	000
00840663105564	K130016	000
00840663105571	K130016	000
00840663105588	K130016	000
00840663105595	K130016	000
00840663105601	K130016	000
00840663105618	K130016	000
00840663105625	K130016	000
00840663105632	K130016	000
00840663105649	K130016	000
00840663106851	K130016	000