pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
FDA 510(k) clearance K191687 · decided 2019-10-09
Clearance details
- K-number
- K191687
- Device name
- pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- Applicant
- Phenox Limited
- Decision
- Substantially Equivalent
- Date received
- 2019-06-24
- Decision date
- 2019-10-09
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Galway, IE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.