The following data is part of a premarket notification filed by Beampoint Ab with the FDA for Beamcath.
| Device ID | K042110 |
| 510k Number | K042110 |
| Device Name: | BEAMCATH |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | BEAMPOINT AB 6740 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance Bundy |
| Correspondent | Constance Bundy BEAMPOINT AB 6740 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-05 |
| Decision Date | 2005-02-25 |
| Summary: | summary |