The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Cardioinsight Cardiac Mapping System.
| Device ID | K181918 |
| 510k Number | K181918 |
| Device Name: | CardioInsight Cardiac Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Janell Colley |
| Correspondent | Janell Colley Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-18 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000118280 | K181918 | 000 |