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Vygon VYPL4S3003SK

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) K172899

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 Number00849884005431 UDI-DI Date28 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172899 Date26 Feb 2018DecidedStatusActive

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  • Withdrawn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
Centrally-inserted central venous catheter
Model / Ref / Catalog
VYPL4S3003SK
Primary DI / UDI-DI
00849884005431
510(k) Number
FDA product code
LJS
GMDN term
Centrally-inserted central venous catheter
Device class
Class II
Regulation number
880.5970
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K172899)

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