# K234083: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Jul 2, 2024 after 193 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K183043 (2019). 4 ancestors in all.
No later device cites it as a predicate yet.
3 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211476: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing, Imperative Care, Inc. (2021) Summary page 4.

## Indications for use
Next Generation Aspiration Catheter: The Next Generation Aspiration Catheter with a compatible aspiration pump and Balt Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV-tPA) or who fail IV-tPA therapy are candidates for treatment. Balt Aspiration Tubing Set: The Balt Aspiration Tubing Set is intended to connect the Next Generation Aspiration Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.

Source page: https://510kreport.com/device/K234083
Methodology: https://510kreport.com/methodology