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FDA 510(k)

THE CDI(R) SYSTEM 400

K-Number: K890113 · 1989-05-23

ApplicantCardiovascular Devices, Inc.
Decision Date1989-05-23
Product CodeDJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE CDI(R) SYSTEM 400 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Devices, Inc.. It received FDA 510(k) clearance on 1989-05-23 under 510(k) number K890113. The device is classified under product code DJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CDI(R) SYSTEM 400?

THE CDI(R) SYSTEM 400 is a medical device that received FDA 510(k) clearance on 1989-05-23. The listed applicant is Cardiovascular Devices, Inc.. The 510(k) number is K890113.

When did THE CDI(R) SYSTEM 400 receive FDA 510(k) clearance?

THE CDI(R) SYSTEM 400 received FDA 510(k) clearance on 1989-05-23, under 510(k) number K890113.

Who is the listed applicant for THE CDI(R) SYSTEM 400?

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

What is the FDA product code for THE CDI(R) SYSTEM 400?

The FDA product code for THE CDI(R) SYSTEM 400 is DJY.

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Other records listing Cardiovascular Devices, 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.

K884228CDI(R) 2000 BLOOD GAS MONITORK871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300K864703MODIFIED GAS-STAT(TM) MONITORING SYSTEMK843912INTRAVASCULAR BLOOD GAS SYSTEMK840749GAST STAT MONITORING SYSTEMK831225GAS-STAT MONITORING SYSTEM

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Related Devices (Code: DJY)

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.

K883615LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73Supelco, Inc.K881361SOLID PHASE EXTRACTION TUBESSupelco, Inc.K850963DUPONT PREP TYPE SI EXTRACITON CARTRIDGEE.I. Dupont DE Nemours & Co., Inc.K840985TRISACRYL GF 05 & TRISACRYL GF 2000Lkb Instruments, Inc.K832198HC40/HC75 PREPACKED COLUMSHamilton Co.K831289PREFILLED IEC COLUMNSBerwick Medical Products, 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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