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Nitroglycerine Pump Set

by Churchill Corp.

510(k) K871084

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871084 Date16 Jul 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nitroglycerine Pump Set is an infusion pump device designed for the administration of nitroglycerine. It is classified as a Class 2 medical device and is intended for use in general hospital settings.

This device is supplied by Churchill Corp. and has FDA 510(k) clearance with the K number K871084. It is regulated under product code FRN and regulation number 880.5725. The device is not specified as single-use or reusable, and no information regarding MRI safety or sterility is provided in the data.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Nitroglycerine Pump Set used for?

    The Nitroglycerine Pump Set is designed for the administration of nitroglycerine in general hospital settings. It is an infusion pump device classified as a Class 2 medical device.

  • Is the Nitroglycerine Pump Set single-use or reusable?

    The device data does not specify whether the Nitroglycerine Pump Set is single-use or reusable. No information regarding sterility or MRI safety is provided in the available data.

  • What regulatory approvals does the Nitroglycerine Pump Set have?

    The Nitroglycerine Pump Set has FDA 510(k) clearance with K number K871084. It is regulated under product code FRN and regulation number 880.5725, classified as a Class 2 medical device.

  • How is the Nitroglycerine Pump Set supplied?

    The Nitroglycerine Pump Set is supplied by Churchill Corp. The device data does not provide specific information about packaging, sizes, or models available.