The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Pacel Bipolar Pacing Catheters.
| Device ID | K152784 |
| 510k Number | K152784 |
| Device Name: | Pacel Bipolar Pacing Catheters |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Contact | Parita Mehta |
| Correspondent | Parita Mehta ST. JUDE MEDICAL 14901 DEVEAU PLACE Minnetonka, MN 55345 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2015-10-22 |
| Summary: | summary |