087 Balloon Guide Catheter System— 510(k) K192525

Name: FDA 510(k) clearance K192525
Creator: U.S. Food and Drug Administration
Published: 2019-10-31

Substantially Equivalent

Q'Apel Medical, LLC

FDA 510(k) clearance K192525 for 087 Balloon Guide Catheter System, Substantially Equivalent on 2019-10-31. Applicant: Q'Apel Medical, LLC. Device class: 2.

Clearance details

Applicant: Q'Apel Medical, LLC
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2019-09-13
Decision date: 2019-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQY

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K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

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.