The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Silicone Foley Catheter.
| Device ID | K161770 |
| 510k Number | K161770 |
| Device Name: | Rusch Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl Teleflex Medical, Inc. 2917 Weck Drive Research Triangle Park, NC 27709 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-28 |
| Decision Date | 2017-05-05 |
| Summary: | summary |