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FDA 510(k)

BAXA PCA INFUSOR

K-Number: K910257 · 1991-11-07

ApplicantBaxa Corp., Sub. of Cook Group, Inc.
Decision Date1991-11-07
Product CodeMEA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BAXA PCA INFUSOR is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K910257. 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 BAXA PCA INFUSOR?

BAXA PCA INFUSOR is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. The 510(k) number is K910257.

When did BAXA PCA INFUSOR receive FDA 510(k) clearance?

BAXA PCA INFUSOR received FDA 510(k) clearance on 1991-11-07, under 510(k) number K910257.

Who is the listed applicant for BAXA PCA INFUSOR?

The FDA 510(k) record lists Baxa Corp., Sub. of Cook Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BAXA PCA INFUSOR?

The FDA product code for BAXA PCA INFUSOR is MEA.

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Other records listing Baxa Corp., Sub. of Cook Group, 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.

K903159VALVE CONTROLLER FOR MICROMACRO COMPOUNDERK904225KWIKMIXK900585TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPK873875BAXA EXACTA-MED PHARMACY PUMPK872743BAXA TUBING SETS (FOR PHARMACY PUMP)K844904CYTOSAFE NEEDLE

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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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