The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Rusch Simplastic Foley Catheters.
| Device ID | K162989 |
| 510k Number | K162989 |
| Device Name: | Rusch Simplastic Foley Catheters |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILLS BLVD Morrisville, NC 27560 |
| Contact | Lori Pfohl |
| Correspondent | Lori Pfohl TELEFLEX MEDICAL, INC. 3015 CARRINGTON MILLS BLVD Morrisville, NC 27560 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-27 |
| Decision Date | 2017-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34026704612551 | K162989 | 000 |
| 24026704612387 | K162989 | 000 |
| 24026704612394 | K162989 | 000 |
| 24026704612400 | K162989 | 000 |
| 34026704612421 | K162989 | 000 |
| 24026704612431 | K162989 | 000 |
| 24026704612448 | K162989 | 000 |
| 34026704612452 | K162989 | 000 |
| 24026704612462 | K162989 | 000 |
| 24026704612479 | K162989 | 000 |
| 24026704612486 | K162989 | 000 |
| 24026704612493 | K162989 | 000 |
| 34026704612506 | K162989 | 000 |
| 24026704612516 | K162989 | 000 |
| 34026704612377 | K162989 | 000 |