The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Modification To Atlantis Pv Imaging Catheter, Model 36456.
| Device ID | K041727 |
| 510k Number | K041727 |
| Device Name: | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 47900 BAYSIDE PKWY. Freemont, CA 94538 |
| Contact | Robert Z Phillips |
| Correspondent | Robert Z Phillips BOSTON SCIENTIFIC SCIMED, INC. 47900 BAYSIDE PKWY. Freemont, CA 94538 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-25 |
| Decision Date | 2004-07-23 |