The following data is part of a premarket notification filed by Sequent Medical, Inc with the FDA for Via 21 Microcatheter.
Device ID | K150894 |
510k Number | K150894 |
Device Name: | VIA 21 Microcatheter |
Classification | Catheter, Percutaneous |
Applicant | SEQUENT MEDICAL, INC 11A COLUMBIA Aliso Viejo, CA 92677 |
Contact | Bethany Barrett |
Correspondent | Bethany Barrett SEQUENT MEDICAL, INC 11A COLUMBIA Aliso Viejo, CA 92677 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-02 |
Decision Date | 2015-08-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851566003918 | K150894 | 000 |