The following data is part of a premarket notification filed by Xre Corp. with the FDA for Unicath Sp Bi-plane (model M269 & M289).
| Device ID | K973744 |
| 510k Number | K973744 |
| Device Name: | UNICATH SP BI-PLANE (MODEL M269 & M289) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Contact | Wayne V Loomer |
| Correspondent | Wayne V Loomer XRE CORP. 300 FOSTER ST. Littleton, MA 01460 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1997-12-29 |