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Mond™ 4141/60

by St. Jude Medical, Inc.

Mond™ 4141/60 is a Class II device made by St. Jude Medical, Inc., cleared under FDA 510(k) K080924 on 30 Apr 2008 and listed in FDA GUDID since 10 Apr 2017 (UDI-DI 05414734504034), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K080924

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 Number05414734504034 UDI-DI Date10 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080924 Date30 Apr 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080924 decided 30 Apr 2008 Active
  • FDA GUDID UDI-DI 05414734504034 listed 10 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080924
  2. Listed FDA GUDID 05414734504034

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mond™
Generic name
Pacing/defibrillation lead stylet
Model / Ref / Catalog
4141/60
Primary DI / UDI-DI
05414734504034
510(k) Number
FDA product code
DRB
GMDN term
Pacing/defibrillation lead stylet
Device class
Class II
Regulation number
870.1380
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Centimeter

Related devices

Category: Pacing/defibrillation lead stylet

Cleared under the same submission (K080924)

and 8 more cleared under K080924

Similar devices

Also classified as Pacing/defibrillation lead stylet.

Similar devices in this category

Other devices filed under Pacing/defibrillation lead stylet.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

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