The following data is part of a premarket notification filed by Vascular Insights Llc with the FDA for Clarivein Catheter.
| Device ID | K071468 |
| 510k Number | K071468 |
| Device Name: | CLARIVEIN CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | VASCULAR INSIGHTS LLC 395 BOSTON POST ROAD Madison, CT 06443 |
| Contact | John P Marano |
| Correspondent | John P Marano VASCULAR INSIGHTS LLC 395 BOSTON POST ROAD Madison, CT 06443 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2008-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30854339004045 | K071468 | 000 |
| 30854339004021 | K071468 | 000 |
| 30854339004014 | K071468 | 000 |