The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Entrac Ureteral Balloon Dilatation Catheters.
| Device ID | K942578 |
| 510k Number | K942578 |
| Device Name: | ENTRAC URETERAL BALLOON DILATATION CATHETERS |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Contact | Sylvia L Gubbe |
| Correspondent | Sylvia L Gubbe AMERICAN MEDICAL SYSTEMS, INC. 11001 BREN RD. EAST Minnetonka, MN 55343 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-08-19 |