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FDA 510(k)

PULSE*SPRAY INJECTOR

K-Number: K963574 · 1997-07-18

ApplicantAngioDynamics, Inc.
Decision Date1997-07-18
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PULSE*SPRAY INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 1997-07-18 under 510(k) number K963574. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the PULSE*SPRAY INJECTOR?

PULSE*SPRAY INJECTOR is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K963574.

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

PULSE*SPRAY INJECTOR received FDA 510(k) clearance on 1997-07-18, under 510(k) number K963574.

Who is the listed applicant for PULSE*SPRAY INJECTOR?

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 INJECTOR?

The FDA product code for PULSE*SPRAY INJECTOR is FRN.

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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.

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