FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K Number: K191687
·
Decision Oct 9, 2019
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
4
Review Days
107
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Basic Information
- Device Name
- pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- K Number
- K191687
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phenox Limited
- Date Received
- June 24, 2019
- Decision Date
- October 9, 2019
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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