5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter— 510(k) K230156

Name: FDA 510(k) clearance K230156
Creator: U.S. Food and Drug Administration
Published: 2023-06-30

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K230156 for 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter, Substantially Equivalent on 2023-06-30. Applicant: Medtronic Vascular. Device class: 2.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2023-01-19
Decision date: 2023-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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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

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K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more2022-04-13
K192296 — Medtronic 6F Taiga Guiding Catheter2019-09-20
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Adverse events under product code DQY

product code DQY

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 →

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