The following data is part of a premarket notification filed by Sequent Medical, Inc with the FDA for Via Microcatheter, Via Plus Microcatheter.
Device ID | K123477 |
510k Number | K123477 |
Device Name: | VIA MICROCATHETER, VIA PLUS MICROCATHETER |
Classification | Catheter, Continuous Flush |
Applicant | SEQUENT MEDICAL, INC 11A COLUMBIA Aliso Viejo, CA 92656 |
Contact | Melanie Parravi |
Correspondent | Melanie Parravi SEQUENT MEDICAL, INC 11A COLUMBIA Aliso Viejo, CA 92656 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-13 |
Decision Date | 2013-03-19 |
Summary: | summary |