Skip to content

Avanti 504611X

by Cordis US Corp.

Avanti 504611X is a Class II device made by Cordis US Corp., cleared under FDA 510(k) K970392 on 24 Apr 1997 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI 10705032010252), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K970392

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705032010252 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970392 Date24 Apr 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970392 decided 24 Apr 1997 Active
  • FDA GUDID UDI-DI 10705032010252 listed 1 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2079-2021 FDA Class II initiated 9 Jun 2021

    The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

    • Terminated Z-1174-2016 FDA Class II initiated 31 Dec 2015

    Incorrect cannula of the sheath introducer (smaller than intended).

Timeline

4 dated events

  1. Cleared FDA 510(k) K970392
  2. Recall initiated FDA recalls Z-1174-2016
  3. Listed FDA GUDID 10705032010252
  4. Recall initiated FDA recalls Z-2079-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Avanti
Generic name
Haemostasis valve
Model / Ref / Catalog
504611X
Primary DI / UDI-DI
10705032010252
510(k) Number
FDA product code
DRE
GMDN term
Haemostasis valve
Device class
Class II
Regulation number
870.1310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemostasis valve

Cleared under the same submission (K970392)

and 8 more cleared under K970392

Similar devices in this category

Other devices filed under Haemostasis valve.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

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