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FDA 510(k)

QUART ARTERIAL FILTER, MODEL HBF 140

K-Number: K001787 · 2000-06-30

ApplicantJostra Medizintechnik AG
Decision Date2000-06-30
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUART ARTERIAL FILTER, MODEL HBF 140 is the device name listed in this FDA 510(k) record. The listed applicant is Jostra Medizintechnik AG. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001787. 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 QUART ARTERIAL FILTER, MODEL HBF 140?

QUART ARTERIAL FILTER, MODEL HBF 140 is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Jostra Medizintechnik AG. The 510(k) number is K001787.

When did QUART ARTERIAL FILTER, MODEL HBF 140 receive FDA 510(k) clearance?

QUART ARTERIAL FILTER, MODEL HBF 140 received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001787.

Who is the listed applicant for QUART ARTERIAL FILTER, MODEL HBF 140?

The FDA 510(k) record lists Jostra Medizintechnik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUART ARTERIAL FILTER, MODEL HBF 140?

The FDA product code for QUART ARTERIAL FILTER, MODEL HBF 140 is DTM.

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 Jostra Medizintechnik 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.

K991864ROTAFLOW CENTRIFUGAL PUMP SYSTEM

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

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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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