Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
FDA 510(k) clearance K201489 · decided 2020-12-22
Clearance details
- K-number
- K201489
- Device name
- Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set
- Applicant
- Argon Medical Devices, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-04
- Decision date
- 2020-12-22
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Athens, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.