Home / 510(k) Clearances / K951602

510(k) K951602

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1995
Date Received
March 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Continuous Flush
Device Class
Class II
Regulation Number
870.1210
Review Panel
CV
Submission Type

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

  • K961763 — PULSE*SPRAY INFUSION SYSTEM (July 17, 1996)
  • K951509 — PULSE*SPRAY INFUSION SYSTEM (June 16, 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 KRA

  • K250794 — InVera Infusion Device (March 12, 2026)
  • K243534 — Micro Catheter (July 30, 2025)
  • K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E2 (November 29, 2023)
  • K231279 — Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3- (July 5, 2023)
  • K231148 — ScleroSafe™ 150 mm, ScleroSafe™ 350 mm (June 20, 2023)
  • K230957 — TriSalus TriNav® LV Infusion System (May 2, 2023)
  • K223139 — Wallaby 017 Micro Catheter (April 25, 2023)
  • K223176 — Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Pl (April 10, 2023)
  • K230636 — Maestro Microcatheter (March 30, 2023)
  • K222679 — Vericor Support Catheter (November 7, 2022)