The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Pressure Display Box,dlp Disposable Pressure Display Sets-non Sterile Versions.
| Device ID | K113235 |
| 510k Number | K113235 |
| Device Name: | PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Amra Racic |
| Correspondent | Amra Racic MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2011-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169880959 | K113235 | 000 |
| 00763000946500 | K113235 | 000 |