pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
FDA 510(k) K191687 · Phenox Limited
510(k) numberK191687
Submission
- Device name
- pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- Applicant
- Phenox Limited
Galway, IE - Received
- June 24, 2019
- Decision date
- October 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire cleared by the FDA?
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (K191687) received a 510(k) decision of Substantially Equivalent on October 9, 2019, 107 days after the submission was received.
What is the product code of K191687?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.