Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled— 510(k) K172236

Name: FDA 510(k) clearance K172236
Creator: U.S. Food and Drug Administration
Published: 2017-10-30

Substantially Equivalent

Avinger, Inc.

FDA 510(k) clearance K172236 for Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled, Substantially Equivalent on 2017-10-30. Applicant: Avinger, Inc.. Device class: 2.

Clearance details

Applicant: Avinger, Inc.
Product code: Code MCW
Device class: Class 2
Regulation: 21 CFR 870.4875
Advisory panel: Cardiovascular
Date received: 2017-07-25
Decision date: 2017-10-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MCW

view all

K260244 — Auryon Atherectomy System2026-04-10
K250723 — FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)2025-04-25
K250385 — Turbo-Elite Laser Atherectomy Catheter2025-03-13
K242757 — Rotarex Atherectomy System2025-01-30
K242947 — FreedomFlow Orbital Circumferential Atherectomy System2024-11-05

More clearances from Avinger, Inc.

view all

K230005 — Pantheris LV Atherectomy Catheter2023-06-06
K230594 — Tigereye ST CTO-Crossing Catheter2023-04-25
K212468 — Tigereye CTO-Crossing Catheter2022-01-06
K212047 — Pantheris System2021-11-16
K201330 — Tigereye CTO-Crossing Catheter2020-09-10

Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.