510(k) K974642 ยท EOQ Bronchoscope (Flexible Or Rigid)
COMBICATH CATHETER
| Applicant | Plastimed Laboratoire Pharmaceutique, Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Dec 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm
Product Code: 58216 27US Terminated |
EOQ | None listed |
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm
58124 40US Terminated |
EOQ | None listed |
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm
Product Code: 58229 19US Terminated |
EOQ | None listed |
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm
Product Code: 58229 19 Terminated |
EOQ | None listed |
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-
COMBICATH 35 cm x 1.9 mm
Product Code: 58 223 19US Terminated |
EOQ | None listed |
| May 27, 2020 | Prodimed Plastimed Division Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm
Product Code: 58 223 19 Terminated |
EOQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.