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Symphony™ ProHelix™ PROHELIX24F

by Imperative Care Inc.

Symphony™ ProHelix™ PROHELIX24F is a Class II device made by Imperative Care Inc., listed in FDA GUDID since 7 Apr 2023 (UDI-DI 00850032079105), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850032079105 UDI-DI Date7 Apr 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Symphony™ ProHelix™
Generic name
Thrombectomy suction catheter
Model / Ref / Catalog
PROHELIX24F
Primary DI / UDI-DI
00850032079105
FDA product code
QEW
GMDN term
Thrombectomy suction catheter
Device class
Class II
Regulation number
870.5150
GUDID distribution status
In Commercial Distribution
Size
Length — 102 Centimeter

Similar devices in this category

Other devices filed under Thrombectomy suction catheter.

Other devices from Imperative Care Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)