ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
FDA 510(k) K173063 · Acist Medical Systems, Inc.
510(k) numberK173063
Submission
- Device name
- ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
- Applicant
- Acist Medical Systems, Inc.
Eden Prairie, MN, US - Received
- September 29, 2017
- Decision date
- October 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterOBJ · Special | 03/20/2020SE |
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| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…DXT · Traditional | 07/18/2019SE |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemOBJ · Traditional | 06/27/2019SE |
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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 (K173063) received a 510(k) decision of Substantially Equivalent on October 23, 2017, 24 days after the submission was received.
What is the product code of K173063?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.