Identity
- Trade Name
- Vis-Rx FDA UDI
- Generic Name
- Coronary optical coherence tomography system catheter FDA UDI
- Device Name
- 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US FDA UDI
- Model / Reference
- US Catheter Kit G30-01 FDA UDI
- Description
- 1.8F Rapid exchange micro-imaging high frequency OCT catheter kit - US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859910007018 FDA UDI
- 510(k) Number
- K192922 FDA UDI
- FDA Product Code
- DQO FDA UDI
- GMDN Term
- Coronary optical coherence tomography system catheter 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
Yes
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 — 1.8 French FDA UDI
Category: Coronary optical coherence tomography system catheter
Vis-Rx by Gentuity, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coronary optical coherence tomography system catheter.
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- Novasight Hybrid™ Catheter — Conavi Medical Inc · Class II
Cleared under the same submission
K192922 also covers:
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
- Gentuity, LLC
Sources (1)
- FDA UDI 31fb342e-3ed1-4238-94a7-0df7e61d8e92 35 fields · synced Jun 7, 2026