Endophys Pressure Sensing Sheath
510(k) K190098
Endophys Pressure Sensing Sheath is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Endophys Holdings, LLC, cleared under FDA 510(k) K190098 on 7 Mar 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190098 | Date7 Mar 2019 | StatusActive |
Official records
- FDA 510(k) database K190098
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DYB
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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