VIA MICROCATHETER, VIA PLUS MICROCATHETER— 510(k) K132652

Clearance details

Applicant

Sequent Medical, Inc.

Product code

Code DQY

Device class

Class 2

Regulation

21 CFR 870.1250

Advisory panel

Cardiovascular

Date received

2013-08-26

Decision date

2013-12-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Aliso Viejo, CA, US

• K260559 — NHanceIT2026-08-14
• K262392 — APRO 35 Swift Catheter2026-08-12
• K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
• K262240 — SSPC NXT Delivery Catheter2026-07-29
• K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

• K162565 — VIA 17 Microcatheter2017-02-18
• K150894 — VIA 21 Microcatheter2015-08-28
• K123477 — VIA MICROCATHETER, VIA PLUS MICROCATHETER2013-03-19

Death

464

Injury

4,489

Malfunction

13,721

Other

2

Total

18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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).Class II·Terminated·Sequent Medical Inc·20160923

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132652.