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FDA 510(k)

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP

K-Number: K911791 · 1991-06-11

ApplicantPharmacia Deltec, Inc.
Decision Date1991-06-11
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Pharmacia Deltec, Inc.. It received FDA 510(k) clearance on 1991-06-11 under 510(k) number K911791. The device is classified under product code MEA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP?

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP is a medical device that received FDA 510(k) clearance on 1991-06-11. The listed applicant is Pharmacia Deltec, Inc.. The 510(k) number is K911791.

When did CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP receive FDA 510(k) clearance?

CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP received FDA 510(k) clearance on 1991-06-11, under 510(k) number K911791.

Who is the listed applicant for CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP?

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

What is the FDA product code for CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP?

The FDA product code for CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP is MEA.

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Other records listing Pharmacia Deltec, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K943310MODEL 6100 AMBULATORY INFUSION SYSTEMK942046PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVEK942161LOCKBOXK942024PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEMK941445EXTENSION SET WITH ANTI-SIPHON VALVEK931073CATH-FINDER

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Related Devices (Code: MEA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpSummit Medical Products, Inc.K170982CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)Smiths Medical Ads, Inc.K143612LifeCare PCA Infusion SystemHospira, Inc.K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0Smiths Medical Asd, Inc.K092313PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEMB.Braun Medical, Inc.K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATORSmiths Medical MD, Inc.

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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