The following data is part of a premarket notification filed by Pursuit Vascular, Inc. with the FDA for Clearguard Hd Antimicrobial Barrier Cap.
| Device ID | K180111 |
| 510k Number | K180111 |
| Device Name: | ClearGuard HD Antimicrobial Barrier Cap |
| Classification | Hemodialysis Catheter Luer End Cap |
| Applicant | Pursuit Vascular, Inc. 6901 East Fish Lake Road, Suite 166 Maple Grove, MN 55369 |
| Contact | Douglas Killion |
| Correspondent | Laurie Lynch Pursuit Vascular, Inc. 6901 East 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 | 2018-01-16 |
| Decision Date | 2018-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709123585 | K180111 | 000 |
| 10887709123592 | K180111 | 000 |