The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Expel Nephroureteral Drainage Stent With Twist-loc Hub System, Expel Ureteral Drainage Stent System.
Device ID | K141344 |
510k Number | K141344 |
Device Name: | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM |
Classification | Stent, Ureteral |
Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
Contact | Matt Beauchane |
Correspondent | Matt Beauchane BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
Product Code | FAD |
CFR Regulation Number | 876.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-22 |
Decision Date | 2014-10-17 |
Summary: | summary |