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Vygon VYLFMM1004

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 found

in data synced 23 Oct 2026

Documents

510(k) K212370

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 Number00849884007312 UDI-DI Date23 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212370 Date29 Aug 2022DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Peripherally-inserted central venous catheter
Model / Ref / Catalog
VYLFMM1004
Primary DI / UDI-DI
00849884007312
510(k) Number
FDA product code
FOZ
GMDN term
Peripherally-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 (K212370)

Other devices from Vygon Corp.

See all devices from Vygon Corp. →

Properties

  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date

Other properties (11)

  • 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
  • Manufacturing date: No