FDA 510(k)

SPARK-KIT(TM)

K-Number: K864509 · 1987-02-18

Decision Date1987-02-18

Product Code

DecisionSubstantially Equivalent

Device Summary

SPARK-KIT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Lyphomed, Inc.. It received FDA 510(k) clearance on 1987-02-18 under 510(k) number K864509. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPARK-KIT(TM)?

SPARK-KIT(TM) is a medical device that received FDA 510(k) clearance on 1987-02-18. The listed applicant is Lyphomed, Inc.. The 510(k) number is K864509.

When did SPARK-KIT(TM) receive FDA 510(k) clearance?

SPARK-KIT(TM) received FDA 510(k) clearance on 1987-02-18, under 510(k) number K864509.

Who is the listed applicant for SPARK-KIT(TM)?

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

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Other records listing Lyphomed, Inc. as applicant

K910142SPARK KIT(R), MODIFICATION K853019NITROGLYCERIN INFUSION SET K853086SECONDARY ADMINISTRATION SET K852882MAXIFILL TRANSFER SET K852881VENTED SECONDARY IV ADMINISTRATION SET K842678I.V. TRANSFER SPIKE

View all 8 devices →

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.