Kodama Catheter 017788
by ACIST Medical Systems, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10841716104203 | Date1 Jul 2026 | StatusListed |
Recalls
-
- Terminated Z-1161-2021
Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Kodama Catheter
- Generic Name
- Intravascular ultrasound imaging catheter, single-use
- Model / Ref / Catalog
- 017788
- Primary DI / UDI-DI
- 10841716104203
- 510(k) Number
- FDA Product Code
- OBJ
- GMDN Term
- Intravascular ultrasound imaging catheter, single-use
- Device Class
- Class II
- Regulation Number
- 870.1200
- GUDID distribution status
- In Commercial Distribution
From the manufacturer
Manufacturer's product page: Kodama®
Other devices from ACIST Medical Systems, Inc.
Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No