Atlas FDA

SureFlo EVD Catheter

FDA 510(k) clearance K170599 · decided 2017-08-31

Clearance details

K-number
K170599
Device name
SureFlo EVD Catheter
Applicant
Arkis Biosciences, Inc.
Decision
Substantially Equivalent
Date received
2017-03-01
Decision date
2017-08-31
Days to decision
183 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Knoxville, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550 recall (Z-2173-2026)Integra LifeSciences Corp. (NeuroSciences)2026-05-13