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510(k) K240940

Vial2Bag Advanced® 20mm Admixture Device by West Pharmaceutical Services, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2024
Date Received
April 5, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by West Pharmaceutical Services, Inc.

  • K163511 — NovaGuard SA Pro Safety System (February 2, 2017)
  • K151777 — Intradermal Adapter (September 29, 2015)
  • K141464 — NOVAGUARD S A SAFETY SYSTEM (September 10, 2014)
  • K123588 — INTRADERMAL ADAPTER (February 19, 2013)
  • K082908 — NOVAGUARD, MODEL 3611001 (April 24, 2009)
  • K041691 — CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT (August 5, 2004)

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