FDA UDI
In Commercial Distribution
🇺🇸 United States
ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor
DI: 00184360000334
·
Model: 9515
·
VOLCANO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ComboWire Pressure/Flow Guide Wrie XT 1.5cm Sensor
- Primary DI
- 00184360000334
- Version / Model
- 9515
- Company Name
- VOLCANO CORPORATION
- Labeler DUNS
- 135179237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 4
- Public Version Date
- 2021-10-26
- Public Version Status
- Update
- Public Device Record Key
- 181d4bfc-2b48-4d2a-b07d-ba887b9ac90a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47486 | Intravascular haemodynamic monitoring system guidewire | A sterile, steerable, component of a haemodynamics monitoring system for the in vivo measurement of blood pressure and/or blood flow velocity in all blood vessels, including the coronary and peripheral arteries, during diagnostic and/or interventional procedures. It typically consists of a long, thin, flexible rod that has built-in pressure/flow measuring transducers/sensors at its working end, and a torque device to facilitate navigation through the vasculature; it has a handle at the proximal end and a cable(s) to connect to the monitoring system. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00184360000334 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042996 | 000 |