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FDA 510(k)

S3 CARDIOPLEGIA CONTROL

K-Number: K962320 · 1997-01-10

ApplicantStoeckert Instrumente
Decision Date1997-01-10
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

S3 CARDIOPLEGIA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Stoeckert Instrumente. It received FDA 510(k) clearance on 1997-01-10 under 510(k) number K962320. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S3 CARDIOPLEGIA CONTROL?

S3 CARDIOPLEGIA CONTROL is a medical device that received FDA 510(k) clearance on 1997-01-10. The listed applicant is Stoeckert Instrumente. The 510(k) number is K962320.

When did S3 CARDIOPLEGIA CONTROL receive FDA 510(k) clearance?

S3 CARDIOPLEGIA CONTROL received FDA 510(k) clearance on 1997-01-10, under 510(k) number K962320.

Who is the listed applicant for S3 CARDIOPLEGIA CONTROL?

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

What is the FDA product code for S3 CARDIOPLEGIA CONTROL?

The FDA product code for S3 CARDIOPLEGIA CONTROL is DTR.

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Other records listing Stoeckert Instrumente 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.

K002273STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAEK001961STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAEK002118STOCKERT COMPACT SYSTEM VERSION 2.0K992635INTERFACE MODULE IDDDK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSK982014STOCKERT COMPACT SYSTEM

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Related Devices (Code: DTR)

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.

K252541Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSpectrum Medical S.R.L.K240908Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)Sorin Group Italia S.R.L.K240190MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System UncoatedMedtronicK223879Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)Quara S.R.L.K220110Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat ExchangerQura S.R.L

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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