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Pressure Tubing VLMF150B

by Edwards Lifesciences LLC

Ref VLMF150B

Pressure Tubing VLMF150B is a device classified as Class IIa in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 0690103D001TDA000SS), cleared under FDA 510(k) K171996 on 23 Oct 2017 and listed in FDA GUDID since 15 Oct 2018 (UDI-DI 07460691944473), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K171996; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171996

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001TDA000SS Basic UDI-DI 07460691944473UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07460691944473 UDI-DI Date15 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK171996 Date23 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001TDA000SS registered 24 Sep 2026 Active
  • FDA 510(k) K171996 decided 23 Oct 2017 Active
  • FDA GUDID UDI-DI 07460691944473 listed 15 Oct 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0413-2024 FDA Class II initiated 4 Oct 2023 on shared 510(k) K171996

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K171996
  2. Listed FDA GUDID 07460691944473
  3. Recall initiated FDA recalls Z-0413-2024
  4. Registered EUDAMED 0690103D001TDA000SS

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pressure Tubing
Generic name
Invasive blood pressure monitoring tubing set
Device name
TruWave Pressure Monitoring Kit Additional accessories
Model / Ref / Catalog
VLMF150B
Primary DI / UDI-DI
07460691944473
Basic UDI-DI
0690103D001TDA000SS
510(k) Number
FDA product code
DXO
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive blood pressure monitoring tubing set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2870
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 60 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Invasive blood pressure monitoring tubing set

Cleared under the same submission (K171996)

and 8 more cleared under K171996

Similar devices in this category

Other devices filed under INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)