Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Pulse* Spray Infusion System, Uni*Fuse Infusion System

K-Number: K163356 · 2017-05-30

ApplicantAngioDynamics, Inc.
Decision Date2017-05-30
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pulse* Spray Infusion System, Uni*Fuse Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2017-05-30 under 510(k) number K163356. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulse* Spray Infusion System, Uni*Fuse Infusion System?

Pulse* Spray Infusion System, Uni*Fuse Infusion System is a medical device that received FDA 510(k) clearance on 2017-05-30. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K163356.

When did Pulse* Spray Infusion System, Uni*Fuse Infusion System receive FDA 510(k) clearance?

Pulse* Spray Infusion System, Uni*Fuse Infusion System received FDA 510(k) clearance on 2017-05-30, under 510(k) number K163356.

Who is the listed applicant for Pulse* Spray Infusion System, Uni*Fuse Infusion System?

The FDA 510(k) record lists AngioDynamics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulse* Spray Infusion System, Uni*Fuse Infusion System?

The FDA product code for Pulse* Spray Infusion System, Uni*Fuse Infusion System is QEY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04229563Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery DiseaseCOMPLETEDNCT04972097Pivotal Study of the NanoKnife System for the Ablation of Prostate TissueCOMPLETEDNCT07640776Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)NOT_YET_RECRUITING

Other records listing AngioDynamics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253198NanoKnife Generator (H78720300351US0)K252509AlphaVac Multipurpose Mechanical Aspiration System F1885K253106AngioVac CannulaK242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)K240397AlphaVac MMA F1885 System (H787253020)K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits

View all 30 devices →

Related Devices (Code: QEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑