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Edwards 10000CR

by Edwards Lifesciences LLC 2 variants

Edwards 10000CR is a Class I device made by Edwards Lifesciences LLC, listed in FDA GUDID since 7 Jan 2025 (UDI-DI 00690103218015), 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 Number00690103218015 UDI-DI Date7 Jan 2025ListedStatusListed 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  • Withdrawn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
Edwards
Generic name
Cardiac implantation catheter platform base, single-use
Model / Ref / Catalog
10000CR
Primary DI / UDI-DI
00690103218015
FDA product code
QWA
GMDN term
Cardiac implantation catheter platform base, single-use
Device class
Class I
Regulation number
870.3955
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiac implantation catheter platform base, single-use

Similar devices

Other devices filed under FDA product code QWA (Cardiovascular Delivery Catheter System Positioning And Stabilization Device).

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)