Flextra Steerable Introducer
FDA 510(k) clearance K170373 · decided 2017-02-27
Clearance details
- K-number
- K170373
- Device name
- Flextra Steerable Introducer
- Applicant
- Rhythm Xience, Inc. (Rxi)
- Decision
- Substantially Equivalent
- Date received
- 2017-02-07
- Decision date
- 2017-02-27
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needl recall (Z-1768-2020) | Acutus Medical Inc | 2020-04-23 |
| Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Tra recall (Z-1769-2020) | Acutus Medical Inc | 2020-04-23 |
| Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Need recall (Z-1770-2020) | Acutus Medical Inc | 2020-04-23 |
| Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Tran recall (Z-1771-2020) | Acutus Medical Inc | 2020-04-23 |