510(k) K171531 ยท KNW Instrument, Biopsy
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle
| Applicant | Care Fusion, Vernon Hills IL, US |
| Decision | Substantially Equivalent, Sep 11, 2017 |
| Received | May 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2021 | Bard Peripheral Vascular Inc Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, F Terminated |
KNW | None listed |
| Aug 24, 2021 | Bard Peripheral Vascular Inc Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion
Intended use to Terminated |
KNW | None listed |
| Jun 23, 2021 | Bard Peripheral Vascular Inc TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm;
TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm;
TJM4011 Jamshidi" Crown B Open, Classified |
KNW | None listed |
| Jun 23, 2021 | Bard Peripheral Vascular Inc EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm Open, Classified |
KNW | None listed |
| Mar 17, 2020 | Bard Peripheral Vascular Inc Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner Terminated |
KNW | None listed |
| Aug 1, 2019 | Becton Dickinson & Company 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC
Catalog Number: TMJ4008 Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.