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FDA 510(k)

PULSE*SPRAY INFUSION SYSTEM

K-Number: K951509 · 1995-06-16

ApplicantAngiodynamics, Div. E-Z-Em, Inc.
Decision Date1995-06-16
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE*SPRAY INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Angiodynamics, Div. E-Z-Em, Inc.. It received FDA 510(k) clearance on 1995-06-16 under 510(k) number K951509. 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?

PULSE*SPRAY INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-16. The listed applicant is Angiodynamics, Div. E-Z-Em, Inc.. The 510(k) number is K951509.

When did PULSE*SPRAY INFUSION SYSTEM receive FDA 510(k) clearance?

PULSE*SPRAY INFUSION SYSTEM received FDA 510(k) clearance on 1995-06-16, under 510(k) number K951509.

Who is the listed applicant for PULSE*SPRAY INFUSION SYSTEM?

The FDA 510(k) record lists Angiodynamics, Div. E-Z-Em, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSE*SPRAY INFUSION SYSTEM?

The FDA product code for PULSE*SPRAY INFUSION SYSTEM is QEY.

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Other records listing Angiodynamics, Div. E-Z-Em, 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.

K961763PULSE*SPRAY INFUSION SYSTEMK951602PULSE*SPRAY INFUSION SYSTEMK950907PULSE*SPRAY INFUSION SYSTEMK933846ANGIOGRAPHY SYRINGE KITSK923120MICROGUIDE LESION MARKING SYSTEM

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

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

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