510(k) K012883 ยท ESW Prosthesis, Esophageal
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Unknown, Oct 12, 2001 |
| Received | Aug 28, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K012883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Tracheobronchial Stent System -
Proximal Release (10/4)
Material/UPN/Catalog Number: M00564670 Terminated |
JCT | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Tracheobronchial Stent System -- Distal Release (10/4/2.5)
Material/UPN/Catalog Number: M00564760 Terminated |
JCT | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (14/4/2.5)
Material/UPN/Catalog Number: M00564800 Terminated |
JCT | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (16/6/4.5)
Material/UPN/Catalog Number: M00564840 Terminated |
JCT | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (18/4/2.5)
Material/UPN/Catalog Number: MOO564860 Terminated |
JCT | None listed |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Tracheobronchial Stent System -
Distal Release (20/6/4.5)
Material/UPN/Catalog Number: M00564900 Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronc Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 8/40 Catalog Number: M00568930. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronc Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 10/20 Catalog Number: M00568940. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 10/40 Catalog Number: M00568950. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 12/20 Catalog Number: M00568960. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 12/40 Catalog Number: M00568970. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 14/20 Catalog Number: M00568980. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 14/80 Catalog Number: M00569000. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 10/30/15 Catalog Number: M00569050. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 12/30/15 Catalog Number: M00569060. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 10/30 Catalog Number: M00569070. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 12/30 Catalog Number: M00569080. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 14/30 Catalog Number: M00569090. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 16/40 Catalog Number: M00569230. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 16/60 Catalog Number: M00569240. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 16/80 Catalog Number: M00569250. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 18/60 Catalog Number: M00569270. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 18/80 Catalog Number: M00569280. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 20/40 Catalog Number: M00569290. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 20/80 Catalog Number: M00569310. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 8/40/25 Catalog Number: M00569410. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 10/40/25 Catalog Number: M00569430. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 12/40/25 Catalog Number: M00569450. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 14/40/25 Catalog Number: M00569480. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 14/60/45 Catalog Number: M00569490. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 18/40/65 Catalog Number: M00569500. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 16/40/25 Catalog Number: M00569510. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 16/60/45 Catalog Number: M00569520. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 16/80/65 Catalog Number: M00569530. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 18/40/25 Catalog Number: M00569540. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 18/60/45 Catalog Number: M00569550. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 18/80/65 Catalog Number: M00569560. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 20/40/25 Catalog Number: M00569570. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 20/60/45 Catalog Number: M00569580. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 20/80/65 Catalog Number: M00569590. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobro Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Uncovered - 14/40 Catalog Number: M00569920. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobron Terminated |
JCT | None listed |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Tracheobronchial Stent System. Covered - 14/60 Catalog Number: M00569930. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronch Terminated |
JCT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.