NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER


Device Classification Name

system, imaging, optical coherence tomography (oct)

510(k) Number K121195
Device Name NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
Applicant
NINEPOINT MEDICAL, INC
1171 barroihet avenue
hillsborough, 
CA 
94010

Applicant Contact cindy domecus
Correspondent
NINEPOINT MEDICAL, INC
1171 barroihet avenue
hillsborough, 
CA 
94010

Correspodent Contact cindy domecus
Regulation Number 892.1560
Classification Product Code
NQQ  
Date Received 04/19/2012
Decision Date 07/25/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No