Next Generation Aspiration Catheter; Balt Aspiration Tubing Set— 510(k) K234083

Name: FDA 510(k) clearance K234083
Creator: U.S. Food and Drug Administration
Published: 2024-07-02

Substantially Equivalent

Balt USA, LLC

FDA 510(k) clearance K234083 for Next Generation Aspiration Catheter; Balt Aspiration Tubing Set, Substantially Equivalent on 2024-07-02. Applicant: Balt USA, LLC. Device class: 2.

Clearance details

Applicant: Balt USA, LLC
Product code: Code NRY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2023-12-22
Decision date: 2024-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K260617 — Tigertriever 13 Ultra Revascularization Device2026-08-28
K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set2026-08-13
K262391 — APRO 35 Swift Catheter and Alembic Aspiration Tubing2026-08-12
K262399 — Millipede System2026-08-12
K260002 — Socrates Aspiration System (Socrates 70 Aspiration Catheter)2026-07-16

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K252700 — Optima Coil System (Optima Packing Coil System)2025-09-26

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.