DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

LEMAITRE VASCULAR, INC.

The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Distal Perfusion Catheter (1.5 Cm) And (2.5cm).

Pre-market Notification Details

• Device ID: K032041
• 510k Number: K032041
• Device Name: DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
• Classification: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
• Applicant: LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Contact: Carlos Chaparro
• Correspondent: Carlos Chaparro; LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803
• Product Code: DWF
• CFR Regulation Number: 870.4210 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-07-01
• Decision Date: 2003-08-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840663101610	K032041	000