The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Trapezoid Rx Lithotripter Compatible Basket, Models 1086, 1087, 1088.
| Device ID | K040447 |
| 510k Number | K040447 |
| Device Name: | TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 |
| Classification | Lithotriptor, Biliary Mechanical |
| Applicant | BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Contact | James D Mcmahon |
| Correspondent | James D Mcmahon BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. Natick, MA 01760 -1537 |
| Product Code | LQC |
| CFR Regulation Number | 876.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-20 |
| Decision Date | 2004-03-12 |
| Summary: | summary |