The following data is part of a premarket notification filed by Sequent Medical, Inc. with the FDA for Via 17 Microcatheter.
Device ID | K162565 |
510k Number | K162565 |
Device Name: | VIA 17 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 92656 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-09-14 |
Decision Date | 2017-02-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00851566003925 | K162565 | 000 |