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Bard Ambulatory PCA Drug Delivery System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K873522

by C. R. Bard, Inc.

Identifiers

510(k) Number
K873522 FDA 510(k)
FDA Product Code
FRN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a pump infusion system designed for patient-controlled analgesia (PCA) drug delivery in an ambulatory setting. It is classified as a Class II medical device under product code FRN and regulation number 880.5725.

The system is supplied by C. R. Bard, Inc. and has received FDA 510(k) clearance under K873522, with a substantially equivalent decision issued on December 29, 1987. It is intended for use in general hospital environments and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.

Frequently asked questions

What is the BARD Ambulatory PCA Drug Delivery System used for?

This device is a pump infusion system designed for patient-controlled analgesia (PCA) drug delivery in an ambulatory setting, allowing patients to self-administer prescribed pain medication as needed within general hospital environments.

Is the BARD Ambulatory PCA Drug Delivery System sterile or single-use?

The provided data does not describe this device as sterile, single-use, or reusable; therefore, its sterility and reuse status cannot be confirmed from the available information and should be verified through official labeling or manufacturer instructions.

What regulatory pathway was used for the BARD Ambulatory PCA Drug Delivery System?

The device received FDA 510(k) clearance under submission K873522, with a substantially equivalent decision issued on December 29, 1987, confirming its regulatory pathway as a traditional 510(k) for Class II devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K873522 FDA 510(k) - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM, K904403 FDA 510(k) - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM, BARD AMBULATORY PCA DRUG DELIVERY SYSTEM (K904403) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K873522 24 fields · synced Sep 25, 2026