The following data is part of a premarket notification filed by Endovations with the FDA for Guide Wire.
| Device ID | K874164 |
| 510k Number | K874164 |
| Device Name: | GUIDE WIRE |
| Classification | Stylet For Catheter, Gastro-urology |
| Applicant | ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Contact | Susan P Bjorkman |
| Correspondent | Susan P Bjorkman ENDOVATIONS 895 POPLAR CHURCH RD. Camp Hill, PA 17011 |
| Product Code | EZB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1987-12-07 |