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FDA 510(k)

COBE SMARXT TUBING AND CONNECTORS

K-Number: K981613 · 1998-10-26

ApplicantCobe Cardiovascular, Inc.
Decision Date1998-10-26
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE SMARXT TUBING AND CONNECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1998-10-26 under 510(k) number K981613. 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 COBE SMARXT TUBING AND CONNECTORS?

COBE SMARXT TUBING AND CONNECTORS is a medical device that received FDA 510(k) clearance on 1998-10-26. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K981613.

When did COBE SMARXT TUBING AND CONNECTORS receive FDA 510(k) clearance?

COBE SMARXT TUBING AND CONNECTORS received FDA 510(k) clearance on 1998-10-26, under 510(k) number K981613.

Who is the listed applicant for COBE SMARXT TUBING AND CONNECTORS?

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

What is the FDA product code for COBE SMARXT TUBING AND CONNECTORS?

The FDA product code for COBE SMARXT TUBING AND CONNECTORS is DWE.

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Other records listing Cobe Cardiovascular, 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.

K050111SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAGK042473COBE ANGEL WHOLE BLOOD SEPARATION SYSTEMK040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTERK033641SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800K030462COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700K021830SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

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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, AGK022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems CorporationK013578PUMP TUBINGTerumo Cardiovascular Systems 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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