RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE


Device Classification Name

catheter,intravascular,therapeutic,short-term less than 30 days

510(k) Number K112347
Device Name RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE
Applicant
VASCULAR PATHWAYS, INC.
8 snowberry court
orinda, 
CA 
94563

Applicant Contact michael a daniel
Correspondent
VASCULAR PATHWAYS, INC.
8 snowberry court
orinda, 
CA 
94563

Correspodent Contact michael a daniel
Regulation Number 880.5200
Classification Product Code
FOZ  
Date Received 08/15/2011
Decision Date 09/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No