The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Endovive Initial Placement Standard Peg Kit With Enfit Connector, Endovive Initial Placement Safety Peg Kit With Enfit Connector.
Device ID | K150679 |
510k Number | K150679 |
Device Name: | EndoVive Initial Placement Standard PEG Kit With ENFit Connector, EndoVive Initial Placement Safety PEG Kit With ENFit Connector |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01756 |
Contact | Virginia Garcia |
Correspondent | Virginia Garcia BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01756 |
Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2015-03-17 |
Decision Date | 2015-05-29 |
Summary: | summary |