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FDA 510(k)

JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...

K-Number: K012617 · 2001-11-06

ApplicantJostra AG
Decision Date2001-11-06
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... is the device name listed in this FDA 510(k) record. The listed applicant is Jostra AG. It received FDA 510(k) clearance on 2001-11-06 under 510(k) number K012617. 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 ARTERIAL PERFUSION CANNULAE, MODEL A...?

JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... is a medical device that received FDA 510(k) clearance on 2001-11-06. The listed applicant is Jostra AG. The 510(k) number is K012617.

When did JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... receive FDA 510(k) clearance?

JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... received FDA 510(k) clearance on 2001-11-06, under 510(k) number K012617.

Who is the listed applicant for JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...?

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 ARTERIAL PERFUSION CANNULAE, MODEL A...?

The FDA product code for JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... 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 & HKVK020515JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA

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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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