Class Class II
Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948)
Description
Raptor Aspiration Catheter; Balt Aspiration Tubing Set by Balt USA, LLC, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243948
Clearance Date2025-06-03
Clearance TypeTraditional
Product CodeNRY
Regulation Number870.1250
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243948
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing... | Balt USA, LLC | 2024 |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiratio... | Imperative Care, Inc. | 2021 |
Trace the full predicate network for K243948
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.