The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Temporary Cardiac Pacing Wire.
| Device ID | K980503 |
| 510k Number | K980503 |
| 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 | Gregory R Jones |
| Correspondent | Gregory R Jones 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 | 1998-02-09 |
| Decision Date | 1998-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031050987 | K980503 | 000 |
| 30705031050970 | K980503 | 000 |