Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Ave. W.
Unit 107
Vancouver, Bc,  CA V6H 1C3
Applicant Contact TIM VERSPAGEN
Correspondent
Angiometrx, Inc.
1099 8th Ave. W.
Unit 107
Vancouver, Bc,  CA V6H 1C3
Correspondent Contact TIM VERSPAGEN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/25/2005
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
Predetermined Change
Control Plan Authorized		 No
-
-