METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K051042
Device Name METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 1000
Applicant
ANGIOMETRX INC.
1099 8th avenue west
unit 107
vancouver, bc, 

CA

v6h 1c3

Applicant Contact tim verspagen
Correspondent
ANGIOMETRX INC.
1099 8th avenue west
unit 107
vancouver, bc, 

CA

v6h 1c3

Correspodent Contact tim verspagen
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 04/25/2005
Decision Date 08/05/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No