The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Endovive One Step Button Low Profile Initial Placement Peg Kit With Enfit Connector, Endovive Low Profile Button Replacement Gastrostomy Tube Kit With Enfit Connector, Endovive Button Right Angle Feeding Set With Enfit Connector, Endovive Button Bolu.
| Device ID | K161003 |
| 510k Number | K161003 |
| Device Name: | EndoVive One Step Button Low Profile Initial Placement PEG Kit With ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit With ENFit Connector, EndoVive Button Right Angle Feeding Set With ENFit Connector, EndoVive Button Bolu |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Virginia Garcia |
| Correspondent | Virginia Garcia BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-06-17 |
| Summary: | summary |