The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Flocath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter.
| Device ID | K181979 |
| 510k Number | K181979 |
| Device Name: | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter |
| Classification | Catheter, Urological |
| Applicant | Teleflex Medical, Inc. 3015 Carrington Mill Blvd, Suite 600 North Morrisville, NC 27560 |
| Contact | Sirisha Kommana |
| Correspondent | Sirisha Kommana Teleflex Medical, Inc. 3015 Carrington Mill Blvd, Suite 600 North Morrisville, NC 27560 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-25 |
| Decision Date | 2019-05-24 |