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510(k) K951509

PULSE*SPRAY INFUSION SYSTEM by Angiodynamics, Div. E-Z-Em, Inc. — Product Code QEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1995
Date Received
April 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mechanical Thrombolysis Catheter
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

To mechanically disrupt thrombus and/or debris in the peripheral vasculature.

Other clearances by Angiodynamics, Div. E-Z-Em, Inc.

  • K961763 — PULSE*SPRAY INFUSION SYSTEM (July 17, 1996)
  • K951602 — PULSE*SPRAY INFUSION SYSTEM (June 14, 1995)
  • K950907 — PULSE*SPRAY INFUSION SYSTEM (May 17, 1995)
  • K933846 — ANGIOGRAPHY SYRINGE KITS (December 13, 1994)
  • K923120 — MICROGUIDE LESION MARKING SYSTEM (September 1, 1992)

Other clearances for product code QEY

  • K260149 — Versus™ Catheter (VS110-9NB) (February 17, 2026)
  • K251318 — VariFuse Adjustable Infusion Catheter (January 20, 2026)
  • K241851 — Versus™ Catheter (VS110-8B) (November 25, 2024)
  • K231653 — BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (July 3, 2023)
  • K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Re (April 20, 2023)
  • K220866 — EKOS+ Endovascular Device (April 20, 2022)
  • K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device (December 14, 2021)
  • K211080 — EkoSonic Endovascular Device (November 19, 2021)
  • K211061 — BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter ( (June 10, 2021)
  • K202347 — UNIFUSE Infusion System with Cooper Wire (September 15, 2020)