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CerebroFlo EVD Catheter Set 37.550.501

by Arkis Biosciences Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10866614000105 UDI-DI Date24 Oct 2019ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2173-2026 FDA Class II initiated 10 Apr 2026

    Out-of-specification endotoxin result that did not meet the acceptance criteria.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
CerebroFlo EVD Catheter Set
Generic Name
Intracerebral infusion/drainage catheter, short-term
Model / Ref / Catalog
37.550.501
Primary DI / UDI-DI
10866614000105
510(k) Number
FDA Product Code
JXG
GMDN Term
Intracerebral infusion/drainage catheter, short-term
Device Class
Class II
Regulation Number
882.5550
GUDID distribution status
Not in Commercial Distribution
Size
Length — 35 Centimeter
Outer Diameter — 3.3 Millimeter

Related devices

Cleared under the same submission (K170599)

Other devices from Arkis Biosciences Inc.

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No