OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05


Device Classification Name

port & catheter, implanted, subcutaneous, intravascular

510(k) Number K021580
Device Name OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
Original Applicant
LEMAITRE VASCULAR, INC.
26 ray ave.
burlington, 
MA 
01803

Original Contact james ashby
Regulation Number 880.5965
Classification Product Code
LJT  
Date Received 05/14/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No