The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Atlantis Pv Imaging Catheter, Model 36456.
| Device ID | K022860 |
| 510k Number | K022860 |
| Device Name: | ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Irene Jaworski |
| Correspondent | Irene Jaworski BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-28 |
| Decision Date | 2002-11-21 |
| Summary: | summary |