510(k) K913306 ยท LWE Bone Marrow Collection/Transfusion Kit
BONE-TEMNO/STERNUM-TEMNO
| Applicant | Proact, Ltd., State College PA, US |
| Decision | Substantially Equivalent, Nov 1, 1991 |
| Received | Jul 25, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913306
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Feb 23, 2017 | Carefusion 2200 Inc ILLINOIS (TJ) NEEDLE ASPIRATION [15GA, 18GA]; STERILE; Terminated |
FSH | None listed |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE; Terminated |
FSH | None listed |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE; Terminated |
FSH | None listed |
| Dec 10, 2010 | Orthofix Inc Orthofix Bone Marrow Aspiration Needle, Catalog number 21-5000, 21-5011, Distributed By: Orthofix Inc, 1720 Bray Central Drive, McKinney, TX 75068-8207. Product includes handle, stylet, cannula, prob Terminated |
LWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.