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 |