The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Rusch Intermittent Urethral Catheters.
| Device ID | K173596 |
| 510k Number | K173596 |
| Device Name: | Rusch Intermittent Urethral Catheters |
| Classification | Catheter, Coude |
| Applicant | Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Contact | Amanda Webb |
| Correspondent | Amanda Webb Teleflex Medical 3015 Carrington Mill Blvd Morrisville, NC 27560 |
| Product Code | EZC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-21 |
| Decision Date | 2018-01-29 |
| Summary: | summary |