The following data is part of a premarket notification filed by Xre Corp. with the FDA for Unicath Ep..
| Device ID | K913685 |
| 510k Number | K913685 |
| Device Name: | UNICATH EP. |
| Classification | System, X-ray, Angiographic |
| Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-11-07 |