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FDA 510(k)

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT

K-Number: K092486 · 2009-08-28

ApplicantVortex Medical, Inc.
Decision Date2009-08-28
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Vortex Medical, Inc.. It received FDA 510(k) clearance on 2009-08-28 under 510(k) number K092486. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT?

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT is a medical device that received FDA 510(k) clearance on 2009-08-28. The listed applicant is Vortex Medical, Inc.. The 510(k) number is K092486.

When did VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT receive FDA 510(k) clearance?

VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT received FDA 510(k) clearance on 2009-08-28, under 510(k) number K092486.

Who is the listed applicant for VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT?

The FDA 510(k) record lists Vortex Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT?

The FDA product code for VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT is DWE.

Related Clinical Trials

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.

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Other records listing Vortex Medical, Inc. 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.

K091304VORTEX CANNULA

Related Devices (Code: DWE)

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.

K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc.K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AGK053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AGK022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems CorporationK013578PUMP TUBINGTerumo Cardiovascular Systems Corp.K993189CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBINGTerumo Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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