Identity
- Trade Name
- ACIST Kodama® Coronary Imaging Catheter FDA UDI
- Generic Name
- Intravascular ultrasound imaging catheter, single-use FDA UDI
- Device Name
- Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag FDA UDI
- Model / Reference
- 017788 FDA UDI
- Description
- Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841716103602 FDA UDI
- 510(k) Number
- K193183 FDA UDI
- FDA Product Code
- OBJ FDA UDI
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravascular ultrasound imaging catheter, single-use
ACIST Kodama® Coronary Imaging Catheter by ACIST Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K193183 also covers:
- ACIST HDi® HD IVUS System — ACIST Medical Systems, Inc.
- ACIST HDi® HD IVUS System — ACIST Medical Systems, Inc.
- ACIST HDi® Linear Translation System (LTS) — ACIST Medical Systems, Inc.
- ACIST HDi® Patient Interface Module (PIM) — ACIST Medical Systems, Inc.
- ACIST HDi® Power Supply — ACIST Medical Systems, Inc.
- ACIST HDi® Power Supply — ACIST Medical Systems, Inc.
- ACIST HDi® System Console — ACIST Medical Systems, Inc.
- ACIST HDi® System Console — ACIST Medical Systems, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ACIST Medical Systems, Inc.
Sources (1)
- FDA UDI f8db9845-3864-44c4-bf3e-4c84125ca616 34 fields · synced Jun 8, 2026