BAROnova Access Sheath Kit
FDA 510(k) clearance K191078 · decided 2019-07-22
Clearance details
- K-number
- K191078
- Device name
- BAROnova Access Sheath Kit
- Applicant
- Baronova, Inc.
- Decision
- Unknown
- Date received
- 2019-04-23
- Decision date
- 2019-07-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- QGG
- Device class
- 2
- Regulation number
- 876.1510
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Carlos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TransPyloric Shuttle/TransPyloric Shuttle Delivery Device (P180024) | Baronova, Inc. | 2019-04-16 |