510(k) K063312 ยท DQO Catheter, Intravascular, Diagnostic
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
| Applicant | Boston Scientific Corp, Fremont CA, US |
| Decision | Substantially Equivalent, Nov 30, 2006 |
| Received | Nov 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063312
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2011 | Boston Scientific Corporation Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Park Terminated |
DQO | None listed |
| Jun 10, 2011 | Boston Scientific Corporation Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Ba Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.