The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Rusch Simplastic Councill Tip Catheter.
| Device ID | K974419 |
| 510k Number | K974419 |
| Device Name: | RUSCH SIMPLASTIC COUNCILL TIP CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Contact | Ronald J Young |
| Correspondent | Ronald J Young RUSCH, INC. 2450 MEADOWBROOK PKWY. Duluth, GA 30096 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-24 |
| Decision Date | 1998-01-27 |
| Summary: | summary |