Nitroglycerine Pump Set
510(k) K871084
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871084 | Date16 Jul 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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.
Other devices from Churchill Corp.
Questions
AI-generated answers, 6 Oct 2026
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.