FDA 510(k), K032041, DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)

Device Classification Name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(k) Number: K032041
Device Name: DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)
Applicant: LEMAITRE VASCULAR, INC.
Regulation Number: 870.4210
Classification Product Code: DWF  
Date Received: 07/01/2003
Decision Date: 08/27/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Type: Traditional

101 pages (57 of 158 original pages are fully redacted)

Contents: 510K Summary, Correspondence, Indications for Use, Substantial Equivalence Table, Directions for Use, CDRH Submission Cover Sheet, 510(k) Notification