Sequent Medical, Inc.
Aliso Viejo, CA, US
Sequent Medical, Inc. appears in FDA device records in Aliso Viejo, CA. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Sequent Medical, Inc. between 2013 and 2017. The busiest year on record is 2013, with 2. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K162565 | VIA 17 Microcatheter | DQY | Substantially Equivalent | |
| K150894 | VIA 21 Microcatheter | DQY | Substantially Equivalent | |
| K132652 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | DQY | Substantially Equivalent | |
| K123477 | VIA MICROCATHETER, VIA PLUS MICROCATHETER | KRA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0114-2017 | VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide). | Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain