FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
K Number: K233904
·
Decision Jul 17, 2024
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
16
Review Days
219
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Basic Information
- Device Name
- ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K Number
- K233904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acist Medical Systems, Inc.
- Date Received
- December 11, 2023
- Decision Date
- July 17, 2024
- Product Code
- DXO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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Other Clearances by Acist Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | May 13, 2026 | Substantially Equivalent |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | May 13, 2026 | Substantially Equivalent |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | Dec 17, 2020 | Substantially Equivalent |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | Mar 20, 2020 | Substantially Equivalent |
| K190473 | ACIST RXi System and Navvus II Catheter | Sep 13, 2019 | Substantially Equivalent |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | Jul 18, 2019 | Substantially Equivalent |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Jun 27, 2019 | Substantially Equivalent |
| K171646 | ACISTCVi® Contrast Delivery System | Feb 16, 2018 | Substantially Equivalent |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | Oct 23, 2017 | Substantially Equivalent |
| K172216 | ACIST RXi Mini System | Aug 18, 2017 | Substantially Equivalent |