ALBOGRAFT VASCULAR PROSTHESIS

Graft, Vascular, Synthetic/biologic Composite

LEMAITRE VASCULAR, INC.

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

Pre-market Notification Details

• Device ID: K093231
• 510k Number: K093231
• Device Name: ALBOGRAFT VASCULAR PROSTHESIS
• Classification: Graft, Vascular, Synthetic/biologic Composite
• Applicant: LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Contact: Erin Daly
• Correspondent: Erin Daly; LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Product Code: MAL
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-14
• Decision Date: 2010-01-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00840663103676	K093231	000
00840663103669	K093231	000
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