Pulse* Spray Infusion System, Uni*Fuse Infusion System— 510(k) K163356

Clearance details

Applicant

AngioDynamics, Inc.

Product code

Code QEY

Device class

Class 2

Regulation

21 CFR 870.5150

Advisory panel

Cardiovascular

Date received

2016-11-30

Decision date

2017-05-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marlborough, MA, US

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• K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 71012023-04-20

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• K231945 — VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits2023-07-20

• Z-1010-2024 — PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.Class II·Ongoing·Angiodynamics, Inc.·20231218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163356.