The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer Guide Tube Set Varisource Luer Tran.
Device ID | K113766 |
510k Number | K113766 |
Device Name: | CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN |
Classification | System, Applicator, Radionuclide, Remote-controlled |
Applicant | VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Contact | Vy Tran |
Correspondent | Vy Tran VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304 |
Product Code | JAQ |
CFR Regulation Number | 892.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-21 |
Decision Date | 2012-03-16 |
Summary: | summary |