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, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K061289
Device Name ARROW PRESSURE INJECTABLE PICC
Applicant
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact ELIZABETH DUNCAN
Correspondent
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact ELIZABETH DUNCAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/09/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-