GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500


Device Classification Name

clamp, vascular

510(k) Number K022880
Device Name GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
Original Applicant
GUIDANT CORP.
3744 mt. diablo blvd.
suite 305
lafayette, 
CA 
94549

Original Contact jeff schakenraad
Regulation Number 870.4450
Classification Product Code
DXC  
Date Received 08/30/2002
Decision Date 09/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls