Class Class II
Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362)
Description
Pounce XL Thrombectomy System (PTS-1011-7F135) by Surmodics,Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241362
Clearance Date2024-09-11
Clearance TypeTraditional
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241362
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. Pounce XL Thrombectomy System (PTS-1011-7F135) (K241362) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231022 | Pounce™ Thrombectomy System | Surmodics,Inc. | 2023 |
| K220501 | Pounce Thrombectomy System | Surmodics,Inc. | 2022 |
Trace the full predicate network for K241362
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.