Identity
- Trade Name
- Inquiry™ FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Model / Reference
- IBI-80440 FDA UDI
Identifiers
- Catalog Number
- IBI-80440 FDA UDI
- Primary DI / UDI-DI
- 05414734301473 FDA UDI
- 510(k) Number
- K946333 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
Dimensions & Sizes
- Size
- Catheter Gauge — 5 French FDA UDI
Category: Cardiac mapping catheter, percutaneous, single-use
Inquiry™ by Irvine Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping catheter, percutaneous, single-use.
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- Woven — Boston Scientific · Class II
- Woven — Boston Scientific · Class II
- AcQRate Dx Steerable Catheter — VascoMed GmbH · Class II
- Map-iT — ACCESS POINT TECHNOLOGIES, INC. · Class II
- Woven — Boston Scientific · Class II
- Woven — Boston Scientific · Class II
- Woven — Boston Scientific · Class II
Cleared under the same submission
K946333 also covers:
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, INC.
- Inquiry™ — IRVINE BIOMEDICAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Irvine Biomedical, Inc.
Sources (1)
- FDA UDI 7dbebfa8-c543-4653-a737-5b71e6d6b066 37 fields · synced Jun 1, 2026