INTRODEUCE DOUBLE LUMEN INTRODUCER


definition

Device Classification Name

introducer, catheter

510(k) Number K001985
Device Name INTRODEUCE DOUBLE LUMEN INTRODUCER
Original Applicant
COOK, INC.
p.o. box 489
bloomington, 
IN 
47402

Original Contact april lavender
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 06/29/2000
Decision Date 01/25/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No