PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K051067
Device Name PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)
Applicant
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Applicant Contact amy watzke
Correspondent
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Correspodent Contact amy watzke
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 04/26/2005
Decision Date 05/27/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls