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FDA 510(k)

COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD

K-Number: K982254 · 1998-09-10

ApplicantCobe Cardiovascular, Inc.
Decision Date1998-09-10
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD 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 1998-09-10 under 510(k) number K982254. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD?

COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD is a medical device that received FDA 510(k) clearance on 1998-09-10. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K982254.

When did COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD receive FDA 510(k) clearance?

COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD received FDA 510(k) clearance on 1998-09-10, under 510(k) number K982254.

Who is the listed applicant for COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD?

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 SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD?

The FDA product code for COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD is DTM.

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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: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, 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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