# K243948: Raptor Aspiration Catheter; Balt Aspiration Tubing Set

- Pathway: 510(k) (Traditional)
- Applicant: Balt USA, LLC
- Decided: Jun 3, 2025 after 162 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: 3 generations back to K183043 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
3 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210996: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Imperative Care, Inc. (2021) Summary page 5.

## Indications for use
Raptor Aspiration Catheter: The Raptor 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 thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment. Balt Aspiration Tubing Set: The Balt Aspiration Tubing Set is intended to connect the Raptor 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/K243948
Methodology: https://510kreport.com/methodology