Edwards Pressure Cable
510(k) K191089
Edwards Pressure Cable is a Class II device made by Edwards Lifesciences LLC, cleared under FDA 510(k) K191089 on 13 Jun 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 | NumberK191089 | Date13 Jun 2019 | StatusActive |
Official records
- FDA 510(k) database K191089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- FDA applicant
- Edwards Lifesciences, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191089
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| FloTrac PSCOEM100MR | PSCOEM100MR / PSCOEM100MR | 00885403532040 | — | On the market |
| HEMOSPHERE PSCOEM100MR | PSCOEM100MR / PSCOEM100MR | 00690103216998 | — | On the market |
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