Skip to content

Ellipsys Medical AMI-6005

by Ellipsys, Inc.

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

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 Number00199874301785 UDI-DIDate3 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Ellipsys Medical
Generic Name
Peripheral vascular electrocautery catheter, single-use
Model / Ref / Catalog
AMI-6005
Primary DI / UDI-DI
00199874301785
FDA Product Code
PQK
GMDN Term
Peripheral vascular electrocautery catheter, single-use
Device Class
Class II
Regulation Number
870.1252
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 6 French

Other devices from Ellipsys, 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