510(k) K021044 ยท BTR Tube, Tracheal (W/Wo Connector)
MADETT
| Applicant | Wolfe Tory Medical, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 11, 2002 |
| Received | Apr 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2016 | Teleflex Medical LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal Terminated |
BTR | None listed |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part Number 10684-003 Terminated |
DYB | None listed |
| Jul 2, 2003 | MedAmicus,Inc Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.