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Vygon VYML5D1003-1

by Vygon Corp.

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

1 closed

Documents

510(k) K181208

FDA submission, from GUDID

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 Number00849884007060 UDI-DI Date30 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181208 Date2 Nov 2018DecidedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0585-2020 FDA Class II initiated 24 Sep 2019

    Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vygon
Generic name
Centrally-inserted central venous catheter
Model / Ref / Catalog
VYML5D1003-1
Primary DI / UDI-DI
00849884007060
510(k) Number
FDA product code
PND
GMDN term
Centrally-inserted central venous catheter
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K181208)

Show all (12)

Other devices from Vygon Corp.

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Properties

  • Single use
  • Implantable
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No