The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Opticross 35 15 Mhz Peripheral Imaging Catheter.
| Device ID | K200733 |
| 510k Number | K200733 |
| Device Name: | Opticross 35 15 MHz Peripheral Imaging Catheter |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Contact | Jennifer L. Foley |
| Correspondent | Jennifer L. Foley Boston Scientific Corporation 3 Scimed Place Maple Grove, MN 55311 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-20 |
| Decision Date | 2020-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08714729984542 | K200733 | 000 |