The following data is part of a premarket notification filed by Endovations with the FDA for Sclerotherapy Injection Catheter.
| Device ID | K860991 |
| 510k Number | K860991 |
| Device Name: | SCLEROTHERAPY INJECTION CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Lifton, Md |
| Correspondent | Lifton, Md ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-17 |
| Decision Date | 1986-05-02 |