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Recana Introducer Sheath, 13Fr x 30cm FG017

by Intervene Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860008103840 UDI-DI Date2 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Recana Introducer Sheath, 13Fr x 30cm
Generic Name
Thrombectomy suction catheter
Model / Reference
FG017
Primary DI / UDI-DI
00860008103840
510(k) Number
FDA Product Code
KRA, QEW
GMDN Term
Thrombectomy suction catheter
Device Class
Class II
Regulation Number
870.1210, 870.5150
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251185)

Other devices from Intervene Inc

See all devices from Intervene Inc →

Properties

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

Other properties (9)

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