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 Wire, Guide, Catheter
510(k) Number K854511
Device Name ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET
Applicant
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Applicant Contact SILPE
Correspondent
Electro-Catheter Corp.
2100 Felver Ct.
P.O. Box 1214c
Rahway,  NJ  07065
Correspondent Contact SILPE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/12/1985
Decision Date 02/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-