The following data is part of a premarket notification filed by St Jude Medical with the FDA for Guardiantm Burr Hole Cover System.
| Device ID | K181382 |
| 510k Number | K181382 |
| Device Name: | GuardianTM Burr Hole Cover System |
| Classification | Cover, Burr Hole |
| Applicant | St Jude Medical 6901 Preston Road Plano, TX 75024 |
| Contact | Rebecca Brunson |
| Correspondent | Rebecca Brunson St Jude Medical 6901 Preston Road Plano, TX 75024 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-25 |
| Decision Date | 2018-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067030297 | K181382 | 000 |
| 05415067030283 | K181382 | 000 |