The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Temporary Cardiac Pacing Wire.
| Device ID | K173923 |
| 510k Number | K173923 |
| Device Name: | Temporary Cardiac Pacing Wire |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Contact | Joice Pappan |
| Correspondent | Joice Pappan Ethicon, Inc. Route 22 West, P.O. Box 151 Somerville, NJ 08876 -0151 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031050970 | K173923 | 000 |
| 10705031050945 | K173923 | 000 |
| 10705031050938 | K173923 | 000 |
| 10705031050921 | K173923 | 000 |