Cardio Flow Peripheral Guide Wire
510(k) K213834
Cardio Flow Peripheral Guide Wire is a Class II device made by Cardio Flow Inc.,, cleared under FDA 510(k) K213834 on 18 Mar 2022, 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 | NumberK213834 | Date18 Mar 2022 | StatusActive |
Official records
- FDA 510(k) database K213834
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K213834
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 | |||
|---|---|---|---|---|
| Cardio Flow Peripheral Guide Wire GW1001 | GW1001 | 00850040691009 | Guidewire Length 325 cm | On the market |
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Other devices filed under FDA product code DQX (Wire, Guide, Catheter).
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