The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Pacel Flow Directed Pacing Catheter.
| Device ID | K161873 |
| 510k Number | K161873 |
| Device Name: | Pacel Flow Directed Pacing Catheter |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345 |
| Contact | Blair Schwartz |
| Correspondent | Blair Schwartz St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-07 |
| Decision Date | 2016-11-22 |
| Summary: | summary |