The following data is part of a premarket notification filed by River Medical, Inc. with the FDA for Disposable Temporary Pacing Wire.
| Device ID | K023174 |
| 510k Number | K023174 |
| Device Name: | DISPOSABLE TEMPORARY PACING WIRE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | RIVER MEDICAL, INC. 836 NE 24TH AVE. Portland, OR 97232 |
| Contact | Mary Ann Greenawalt |
| Correspondent | Mary Ann Greenawalt RIVER MEDICAL, INC. 836 NE 24TH AVE. Portland, OR 97232 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-23 |
| Decision Date | 2003-06-11 |
| Summary: | summary |