The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Pta Balloon Dilatation Catheter.
Device ID | K141150 |
510k Number | K141150 |
Device Name: | PTA BALLOON DILATATION CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
Contact | Carol Tiffany |
Correspondent | Carol Tiffany BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-05 |
Decision Date | 2014-09-25 |
Summary: | summary |