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FDA 510(k)

JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA

K-Number: K020515 · 2002-04-24

ApplicantJostra AG
Decision Date2002-04-24
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Jostra AG. It received FDA 510(k) clearance on 2002-04-24 under 510(k) number K020515. 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 JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA?

JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA is a medical device that received FDA 510(k) clearance on 2002-04-24. The listed applicant is Jostra AG. The 510(k) number is K020515.

When did JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA receive FDA 510(k) clearance?

JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA received FDA 510(k) clearance on 2002-04-24, under 510(k) number K020515.

Who is the listed applicant for JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA?

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 JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA?

The FDA product code for JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA is DWF.

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Other records listing Jostra AG 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.

K020983JOSTRA SUCKERS, MODEL JSK030264QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030K020784JOSTRA SINGLE STAGE VENOUS RETURN CATHETERSK023132JOSTRA MECC SYSTEMK022022JOSTRA VENT CATHETERS, MODELS LV & HKVK014303JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE

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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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