The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Stingray Lp Catheter.
Device ID | K152401 |
510k Number | K152401 |
Device Name: | Stingray LP Catheter |
Classification | Catheter, Percutaneous |
Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
Contact | Kurtis Hunsberger |
Correspondent | Kurtis Hunsberger BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-25 |
Decision Date | 2015-12-04 |
Summary: | summary |