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FDA 510(k)

PUMP TUBING WITH X-COATING

K-Number: K022857 · 2002-09-19

ApplicantTerumo Cardiovascular Systems Corporation
Decision Date2002-09-19
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PUMP TUBING WITH X-COATING is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2002-09-19 under 510(k) number K022857. 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 PUMP TUBING WITH X-COATING?

PUMP TUBING WITH X-COATING is a medical device that received FDA 510(k) clearance on 2002-09-19. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K022857.

When did PUMP TUBING WITH X-COATING receive FDA 510(k) clearance?

PUMP TUBING WITH X-COATING received FDA 510(k) clearance on 2002-09-19, under 510(k) number K022857.

Who is the listed applicant for PUMP TUBING WITH X-COATING?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PUMP TUBING WITH X-COATING?

The FDA product code for PUMP TUBING WITH X-COATING is DWE.

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Other records listing Terumo Cardiovascular Systems Corporation 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.

K234065CDI OneView Monitoring SystemK221895Terumo Advanced Perfusion System 1K200091Capiox iCP Centrifugal PumpK182110CDI Blood Parameter Monitoring System 550K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)

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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.K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AGK053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AGK013578PUMP TUBINGTerumo Cardiovascular Systems Corp.K993189CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBINGTerumo Corp.

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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