The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Interject Injection Therapy Needle Catheter.
| Device ID | K171454 |
| 510k Number | K171454 |
| Device Name: | Interject Injection Therapy Needle Catheter |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Tara Paul |
| Correspondent | Tara Paul Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-17 |
| Decision Date | 2017-07-07 |
| Summary: | summary |