The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Atlantis 018 Peripheral Imaging Catheter.
| Device ID | K073623 |
| 510k Number | K073623 |
| Device Name: | ATLANTIS 018 PERIPHERAL IMAGING CATHETER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | Emilly Tojima |
| Correspondent | Emilly Tojima BOSTON SCIENTIFIC CORP. 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-03-13 |
| Summary: | summary |