INNER-LOCK LOCKING INTRODUCER SHEATHS


Device Classification Name

introducer, catheter

510(k) Number K022170
Device Name INNER-LOCK LOCKING INTRODUCER SHEATHS
Original Applicant
REX MEDICAL
55 northern blvd.
suite 200
great neck, 
NY 
11021

Original Contact susan d goldstein-falk
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 07/03/2002
Decision Date 01/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No