The following data is part of a premarket notification filed by Rusch, Inc. with the FDA for Low Profile Catheter.
| Device ID | K922567 |
| 510k Number | K922567 |
| Device Name: | LOW PROFILE CATHETER |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | J Brozowski |
| Correspondent | J Brozowski RUSCH, INC. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-01 |
| Decision Date | 1995-11-21 |