The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Selectsite C304-his Deflectable Catheter System.
| Device ID | K183493 |
| 510k Number | K183493 |
| Device Name: | SelectSite C304-HIS Deflectable Catheter System |
| Classification | Catheter, Percutaneous |
| Applicant | Medtronic Inc. Parkmore Business Park West Galway, IE |
| Contact | Sharon Fahy |
| Correspondent | Linda O'connor Medtronic Inc. Parkmore Business Park West Galway, IE |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000147006 | K183493 | 000 |
| 00763000147013 | K183493 | 000 |