The following data is part of a premarket notification filed by Vascular Insights, Llc with the FDA for Clarivein Ic.
| Device ID | K153502 |
| 510k Number | K153502 |
| Device Name: | ClariVein IC |
| Classification | Catheter, Continuous Flush |
| Applicant | VASCULAR INSIGHTS, LLC 1 PINE HILL DRIVE, TWO BATTERYMARCH PARK, SUITE 100 Quincy, MA 02169 |
| Contact | Lorraine M. Hanley |
| Correspondent | Lorraine M. Hanley VASCULAR INSIGHTS, LLC 1 PINE HILL DRIVE, TWO BATTERYMARCH PARK, SUITE 100 Quincy, MA 02169 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-07 |
| Decision Date | 2016-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450412821 | K153502 | 000 |
| 10884450412814 | K153502 | 000 |
| 10884450412838 | K153502 | 000 |
| 10884450429263 | K153502 | 000 |
| 00884450429280 | K153502 | 000 |
| 00884450429242 | K153502 | 000 |