510(k) K031057 ยท JOH Tube Tracheostomy And Tube Cuff
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
| Applicant | Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jul 18, 2003 |
| Received | Apr 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2007 | Smiths Medical ASD, Inc. Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile
Ref: 536090 Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm
Product Number:
535070 Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm
Product Number: 535080 Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm
Product Number: 535090 Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 7.0mm
Product Number: 538070E Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm
Product Number: 538080E Terminated |
JOH | None listed |
| Jun 4, 2005 | Smiths Medical ASD, Inc. Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm
Product Number: 538090E Terminated |
JOH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.