The following data is part of a premarket notification filed by Entracare, Llc with the FDA for Advanced Urological Catheter.
| Device ID | K053429 |
| 510k Number | K053429 |
| Device Name: | ADVANCED UROLOGICAL CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | ENTRACARE, LLC 11315 STRANG LINE RD. Lenexa, KS 66215 |
| Contact | Al Boedeker |
| Correspondent | Al Boedeker ENTRACARE, LLC 11315 STRANG LINE RD. Lenexa, KS 66215 |
| Product Code | EZL |
| Subsequent Product Code | FCM |
| Subsequent Product Code | FCN |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-02-08 |
| Summary: | summary |