Inquiry™ IBI-81930
Inquiry™ IBI-81930 is a Class II device made by Irvine Biomedical, Inc., cleared under FDA 510(k) K991878 on 10 Dec 1999 and listed in FDA GUDID since 11 Mar 2015 (UDI-DI 05414734306249), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05414734306249 | Date11 Mar 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991878 | Date10 Dec 1999 | StatusActive |
Official records
- AccessGUDID record 05414734306249
- FDA 510(k) database K991878
Across registries
- FDA 510(k) K991878 decided 10 Dec 1999 Active
- FDA GUDID UDI-DI 05414734306249 listed 11 Mar 2015 Listed
Timeline
- Cleared FDA 510(k) K991878
- Listed FDA GUDID 05414734306249
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Inquiry™
- Generic name
- Cardiac mapping catheter, percutaneous, single-use
- Model / Ref / Catalog
- IBI-81930
- Primary DI / UDI-DI
- 05414734306249
- 510(k) Number
- FDA product code
- DRF
- GMDN term
- Cardiac mapping catheter, percutaneous, single-use
- Device class
- Class II
- Regulation number
- 870.1220
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Gauge — 7 French
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