The following data is part of a premarket notification filed by Daig Corp. with the FDA for Disposable Bipolar Temporary Pacing Electrode.
| Device ID | K875059 |
| 510k Number | K875059 |
| Device Name: | DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | J Fleischhacker |
| Correspondent | J Fleischhacker DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15414734027288 | K875059 | 000 |
| 15414734001073 | K875059 | 000 |
| 15414734001097 | K875059 | 000 |
| 15414734001110 | K875059 | 000 |
| 15414734001134 | K875059 | 000 |
| 15414734001158 | K875059 | 000 |
| 15414734001172 | K875059 | 000 |
| 15414734001196 | K875059 | 000 |
| 15414734001219 | K875059 | 000 |
| 15414734001233 | K875059 | 000 |
| 15414734026519 | K875059 | 000 |
| 15414734001059 | K875059 | 000 |