510(k) K180111
- Device
- ClearGuard HD Antimicrobial Barrier Cap
- Applicant
- Pursuit Vascular, Inc.
- 510(k) number
- K180111
- Product code
- PEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-25
- Date received
- 2018-01-16
- Regulation
- 876.5540
- Classification name
- Hemodialysis Catheter Luer End Cap
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Douglas Killion
- Address
- 6901 E. Fish Lake Rd., Suite 166 Maple Grove MN US 55369 55369
FDA Registration Numbers#
- 1423662
- 3011088743
- 2025816
- 1713468
- 1720929
- 3013319212
Source Documents#
Other 510(k) Records For Product Code PEH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131060 | CLEARGUARD HD END CAP | Pursuit Vascular, Inc. | 2013-12-16 |
Legacy Summary#
summary
FDA Review#
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