Flextra Steerable Introducer— 510(k) K170373
Substantially EquivalentRhythm Xience, Inc. (Rxi)
FDA 510(k) clearance K170373 for Flextra Steerable Introducer, Substantially Equivalent on 2017-02-27. Applicant: Rhythm Xience, Inc. (Rxi). Device class: 2.
Clearance details
- Applicant
- Rhythm Xience, Inc. (Rxi)
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DYB
view allMore clearances from Rhythm Xience, Inc. (Rxi)
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170373
K-number listed on FDA's recall record- Z-1768-2020 — Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
- Z-1769-2020 — Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
- Z-1770-2020 — Rhythm Xience Flextra Steerable Introducer with Lancer Integrated Dilator/Transseptal Needle, REF: 122852, Sterile EO, RxOnly
- Z-1771-2020 — Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170373.
Data sourced from openFDA. This site is unofficial and independent of the FDA.