The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, And Clear Renal Sheath.
| Device ID | K172929 |
| 510k Number | K172929 |
| Device Name: | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, And Clear Renal Sheath |
| Classification | Catheter, Nephrostomy |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Daniel Fitzdaniel |
| Correspondent | Daniel Fitzdaniel Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2018-01-10 |
| Summary: | summary |