510(k) K080272 ยท ITX Transducer, Ultrasonic, Diagnostic
ATLANTIS PVIMAGING CATHETER, MODEL H749364560
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Mar 11, 2008 |
| Received | Feb 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2014 | Boston Scientific Corporation Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter:
Sterile, R; Sterilized using irradiation.
Product Usage:
This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an I Terminated |
ITX | None listed |
| Jan 28, 2009 | Boston Scientific Corporation Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA.
Medical device, intended for ultrasound examination Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.