The following data is part of a premarket notification filed by Onset Medical Corporation with the FDA for Pathway Balloon Expandable Ureteral Access Sheath, Model Beus.
| Device ID | K061009 |
| 510k Number | K061009 |
| Device Name: | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | ONSET MEDICAL CORPORATION 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego ONSET MEDICAL CORPORATION 27001 LA PAZ SUITE 312 Mission Viejo, CA 92691 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-12 |
| Decision Date | 2006-05-02 |