BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095)
Description
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 by Thrombolex, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
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Predicate lineage for K222095
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. BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 En... | Thrombolex, Inc. | 2021 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endova... | Thrombolex, Inc. | 2023 |
Trace the full predicate network for K222095
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.