The following data is part of a premarket notification filed by Pursuit Vascular, Inc with the FDA for Clearguard Hd End Cap.
| Device ID | K131060 |
| 510k Number | K131060 |
| Device Name: | CLEARGUARD HD END CAP |
| Classification | Hemodialysis Catheter Luer End Cap |
| Applicant | PURSUIT VASCULAR, INC 6901 E. FISH LAKE ROAD SUITE 166 Maple Grove, MN 55369 |
| Contact | Laurie E Lynch, Ph.d. |
| Correspondent | Laurie E Lynch, Ph.d. PURSUIT VASCULAR, INC 6901 E. FISH LAKE ROAD SUITE 166 Maple Grove, MN 55369 |
| Product Code | PEH |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-16 |
| Decision Date | 2013-12-16 |
| Summary: | summary |