ClearGuard HD Antimicrobial Barrier Cap
FDA 510(k) clearance K180111 · decided 2018-05-25
Clearance details
- K-number
- K180111
- Device name
- ClearGuard HD Antimicrobial Barrier Cap
- Applicant
- Pursuit Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-16
- Decision date
- 2018-05-25
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- PEH
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CLEARGUARD HD END CAP (K131060) | Pursuit Vascular, Inc. | 2013-12-16 |
Recalls involving this device
No recalls on record reference this clearance.