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FDA 510(k)

ELS CANNULA (KIT), MODEL M1210-88,M1510-88

K-Number: K002857 · 2000-10-05

ApplicantJostra AG
Decision Date2000-10-05
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELS CANNULA (KIT), MODEL M1210-88,M1510-88 is the device name listed in this FDA 510(k) record. The listed applicant is Jostra AG. It received FDA 510(k) clearance on 2000-10-05 under 510(k) number K002857. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELS CANNULA (KIT), MODEL M1210-88,M1510-88?

ELS CANNULA (KIT), MODEL M1210-88,M1510-88 is a medical device that received FDA 510(k) clearance on 2000-10-05. The listed applicant is Jostra AG. The 510(k) number is K002857.

When did ELS CANNULA (KIT), MODEL M1210-88,M1510-88 receive FDA 510(k) clearance?

ELS CANNULA (KIT), MODEL M1210-88,M1510-88 received FDA 510(k) clearance on 2000-10-05, under 510(k) number K002857.

Who is the listed applicant for ELS CANNULA (KIT), MODEL M1210-88,M1510-88?

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

What is the FDA product code for ELS CANNULA (KIT), MODEL M1210-88,M1510-88?

The FDA product code for ELS CANNULA (KIT), MODEL M1210-88,M1510-88 is DWF.

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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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