510(k) K191078
- Device
- BAROnova Access Sheath Kit
- Applicant
- BAROnova, Inc.
- 510(k) number
- K191078
- Product code
- QGG
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2019-07-22
- Date received
- 2019-04-23
- Regulation
- 876.1510
- Classification name
- Esophageal Sheath With Distal Balloon Anchor
- 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
- Lian Cunningham
- Address
- 1551 Industrial Rd. San Carlos CA US 94070 94070
Source Documents#
Legacy Summary#
summary
FDA Review#
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