The following data is part of a premarket notification filed by Endovations with the FDA for Steerable Catheter System.
| Device ID | K862424 |
| 510k Number | K862424 |
| Device Name: | STEERABLE CATHETER SYSTEM |
| Classification | Endoscope, Ac-powered And Accessories |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Karen S Butt |
| Correspondent | Karen S Butt ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | GCP |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-26 |
| Decision Date | 1986-09-22 |