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 K001251
Device Name SNIPER, MODEL OR-3872XX SERIES
Applicant
NIPRO MEDICAL CORP.
1445 FLAT GREEK RD.
ATHENS,  TX 
Applicant Contact JACK FRAUTSCHI
Correspondent
NIPRO MEDICAL CORP.
1445 FLAT GREEK RD.
ATHENS,  TX 
Correspondent Contact JACK FRAUTSCHI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received04/19/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-