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FDA 510(k)

ELECATH PULSATILE PERFUSION PUMP

K-Number: K854975 · 1986-01-15

ApplicantElectro-Catheter Corp.
Decision Date1986-01-15
Product CodeKFM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECATH PULSATILE PERFUSION PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1986-01-15 under 510(k) number K854975. 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 ELECATH PULSATILE PERFUSION PUMP?

ELECATH PULSATILE PERFUSION PUMP is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K854975.

When did ELECATH PULSATILE PERFUSION PUMP receive FDA 510(k) clearance?

ELECATH PULSATILE PERFUSION PUMP received FDA 510(k) clearance on 1986-01-15, under 510(k) number K854975.

Who is the listed applicant for ELECATH PULSATILE PERFUSION PUMP?

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

What is the FDA product code for ELECATH PULSATILE PERFUSION PUMP?

The FDA product code for ELECATH PULSATILE PERFUSION PUMP is KFM.

Related Clinical Trials

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Other records listing Electro-Catheter 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.

K934785MULTIPACEK933451OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK933450CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATIONK943257TIP DEFLECTOR (GENESIS)K934787SILICORE SEMI-FLOATERK874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER

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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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