510(k) K200733 ยท ITX Transducer, Ultrasonic, Diagnostic
Opticross 35 15 MHz Peripheral Imaging Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 17, 2020 |
| Received | Mar 20, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 24, 2020 | Boston Scientific Corporation Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021
Material Number (UPN) # H7493932800350
UDI # 08714729984542
Lot #25754545; 25852104 Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.