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Eagle Eye Platinum ST RX Digital IVUS Catheter 85900PST

by Philips Image Guided Therapy Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number00845225003371 UDI-DI Date24 Sep 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Eagle Eye Platinum ST RX Digital IVUS Catheter
Generic Name
Intravascular ultrasound imaging catheter, single-use
Model / Ref / Catalog
85900PST
Primary DI / UDI-DI
00845225003371
510(k) Number
FDA Product Code
OBJ, ITX
GMDN Term
Intravascular ultrasound imaging catheter, single-use
Device Class
Class II
Regulation Number
870.1200, 892.1570
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 150 Centimeter

Related devices

Cleared under the same submission (K143701)

Other devices from Philips Image Guided Therapy Corporation

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Properties

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

Other properties (8)

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