Skip to content

Fast-Cath™ 406845

by St. Jude Medical, Inc.

Fast-Cath 406845 is a vascular catheter introduction set (FDA Class II; FDA product code DYB, Introducer, Catheter) made by St. Jude Medical, Inc., cleared under FDA 510(k) K061015 on 3 Aug 2006 and listed in FDA GUDID since 11 Apr 2015 (UDI-DI 05414734202947), active as of 9 Nov 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 9 Nov 2026

Documents

510(k) K061015

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05414734202947 UDI-DI Date11 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK061015 Date3 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061015 decided 3 Aug 2006 Active
  • FDA GUDID UDI-DI 05414734202947 listed 11 Apr 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061015
  2. Listed FDA GUDID 05414734202947

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fast-Cath™
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
406845
Primary DI / UDI-DI
05414734202947
510(k) Number
FDA product code
DYB
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8 French
Length — 63.0000 Centimeter

Related devices

Category: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K061015)

and 8 more cleared under K061015

Similar devices in this category

Other devices filed under Vascular catheter introduction set, nonimplantable.

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)