510(k) K063091 ยท FTL Mesh, Surgical, Polymeric
PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601
| Applicant | Tyrx Pharma, Inc., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Jan 16, 2008 |
| Received | Oct 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063091
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2016 | TYRX Inc. TRYX Antibacterial Envelope Rx Only
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | None listed |
| Jun 29, 2016 | TYRX Inc. TRYX Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | None listed |
| Jun 29, 2016 | TYRX Inc. TRYX Neuro Absorbable Antibacterial Envelope
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.