510(k) K021721 ยท DQY Catheter, Percutaneous
EQUALIZER BALLOON CATHETER
| Applicant | Boston Scientific Corp, Natick, MA, US |
| Decision | Substantially Equivalent, Jun 20, 2002 |
| Received | May 24, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021721
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | None listed |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | None listed |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | None listed |
| Nov 13, 2009 | Boston Scientific Corporation Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.