510(k) K192247 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Steripath Gen2 Blood Collection System
| Applicant | Magnolia Medical Technologies, Inc., Seattle WA, US |
| Decision | Substantially Equivalent, Feb 28, 2020 |
| Received | Aug 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192247
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2021 | Magnolia Medical Technologies, Inc. The Steripath Gen2 Blood Collection System
Model Number/Description
2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck
2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wid Terminated |
JKA | None listed |
| Aug 2, 2021 | Magnolia Medical Technologies, Inc. Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer Blood Collection or Urine Colle Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.