Surfacer Inside-Out Access Catheter System
FDA 510(k) clearance DEN190038 · decided 2020-02-10
Clearance details
- K-number
- DEN190038
- Device name
- Surfacer Inside-Out Access Catheter System
- Applicant
- Bluegrass Vascular Technologies, Inc.
- Decision
- Unknown
- Date received
- 2019-08-15
- Decision date
- 2020-02-10
- Days to decision
- 179 days
- Clearance type
- Direct
- Product code
- QJH
- Device class
- 2
- Regulation number
- 870.1342
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, 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 |
|---|---|---|
| Surfacer Inside-Out Access Catheter System (K252527) | Merit Medical System, Inc. | 2025-09-10 |
Recalls involving this device
No recalls on record reference this clearance.