The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Selectsite C304 Deflectable Catheter System, Models C304-s59, C304-l69, C304-xs59 & C304-xl74.
| Device ID | K061416 |
| 510k Number | K061416 |
| Device Name: | SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDTRONIC VASCULAR 1015 GRAMSIE ROAD Shoreview, MN 55126 -3082 |
| Contact | Michelle Nivala |
| Correspondent | Michelle Nivala MEDTRONIC VASCULAR 1015 GRAMSIE ROAD Shoreview, MN 55126 -3082 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2006-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994729798 | K061416 | 000 |
| 00613994729781 | K061416 | 000 |
| 00613994729774 | K061416 | 000 |