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FDA 510(k)

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE

K-Number: K875094 · 1988-02-29

ApplicantPall Biomedical Products Co.
Decision Date1988-02-29
Product CodeKRJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Pall Biomedical Products Co.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K875094. The device is classified under product code KRJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE?

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K875094.

When did ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE receive FDA 510(k) clearance?

ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE received FDA 510(k) clearance on 1988-02-29, under 510(k) number K875094.

Who is the listed applicant for ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE?

The FDA 510(k) record lists Pall Biomedical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE?

The FDA product code for ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE is KRJ.

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Other records listing Pall Biomedical Products Co. 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.

K954331PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)K960993PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)K905794PALL 3N1 FILTERK902518LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICEK884534PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTERK875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE

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Related Devices (Code: KRJ)

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.

K990276POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K982385POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.K940126AVECOR PRE-BYPASS FILTERAvecor Cardiovascular, Inc.K900672PREBYPASS FILTER, CAT. NO. FPB-5American Omni Medical, Inc.K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMMedtronic Blood Systems, Inc.K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, 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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