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FDA 510(k)

CENTRIMED SYSTEM 1

K-Number: K842007 · 1984-08-03

ApplicantCentrimed Corp.
Decision Date1984-08-03
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTRIMED SYSTEM 1 is the device name listed in this FDA 510(k) record. The listed applicant is Centrimed Corp.. It received FDA 510(k) clearance on 1984-08-03 under 510(k) number K842007. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIMED SYSTEM 1?

CENTRIMED SYSTEM 1 is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Centrimed Corp.. The 510(k) number is K842007.

When did CENTRIMED SYSTEM 1 receive FDA 510(k) clearance?

CENTRIMED SYSTEM 1 received FDA 510(k) clearance on 1984-08-03, under 510(k) number K842007.

Who is the listed applicant for CENTRIMED SYSTEM 1?

The FDA 510(k) record lists Centrimed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIMED SYSTEM 1?

The FDA product code for CENTRIMED SYSTEM 1 is KFM.

Related Clinical Trials

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.

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Other records listing Centrimed Corp. 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.

K851615CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVEK851613CENTRIMED SYSTEM 1 W/SYSTEM 1 ADAPTERK851614CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY

Related Devices (Code: KFM)

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.

K251762Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)Spectrum Medical S.R.L.K250326Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)Spectrum Medical S.R.L.K233091Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)Qura S.R.LK232132LifeSPARC SystemCardiacassist, Inc.K220842Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsQura S.R.LK200091Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation

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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