The following data is part of a premarket notification filed by Boston Scientific with the FDA for Permanent Sled Bag.
| Device ID | K152403 |
| 510k Number | K152403 |
| Device Name: | Permanent Sled Bag |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BOSTON SCIENTIFIC 47215 Lakeview Blvd. Fremont, CA 94538 |
| Contact | George J. Prendergast |
| Correspondent | George J. Prendergast BOSTON SCIENTIFIC 47215 Lakeview Blvd. 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 | 2015-08-25 |
| Decision Date | 2015-09-22 |
| Summary: | summary |