ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
FDA 510(k) K191175 · Acist Medical Systems, Inc.
510(k) numberK191175
Submission
- Device name
- ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- Applicant
- Acist Medical Systems, Inc.
Eden Prairie, MN, US - Received
- May 1, 2019
- Decision date
- June 27, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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| K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid…OBJ · Special | Abbott Medical | 05/23/2025SE |
| K251231 | ViewFlex X ICE Catheter, Sensor EnabledOBJ · Special | Abbott Medical | 05/20/2025SE |
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| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemDXT · Special | 12/17/2020SE |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | 03/20/2020SE |
| K190473 | ACIST RXi System and Navvus II CatheterOBI · Traditional | 09/13/2019SE |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | 07/18/2019SE |
| K171646 | ACISTCVi® Contrast Delivery SystemDXT · Traditional | 02/16/2018SE |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Special | 10/23/2017SE |
Questions and answers
When was ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System cleared by the FDA?
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K191175) received a 510(k) decision of Substantially Equivalent on June 27, 2019, 57 days after the submission was received.
What is the product code of K191175?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.