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FDA 510(k)

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE

K-Number: K874405 · 1987-12-30

ApplicantPall Biomedical Products Co.
Decision Date1987-12-30
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE 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 1987-12-30 under 510(k) number K874405. The device is classified under product code JOD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE?

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE is a medical device that received FDA 510(k) clearance on 1987-12-30. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K874405.

When did PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE receive FDA 510(k) clearance?

PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE received FDA 510(k) clearance on 1987-12-30, under 510(k) number K874405.

Who is the listed applicant for PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE?

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 PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE?

The FDA product code for PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE is JOD.

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 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 FILTERK875094ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE

View all 28 devices →

Related Devices (Code: JOD)

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.

K993060GAS FILTEROlson Medical Sales, Inc.K890504CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUSGish Biomedical, Inc.K875095PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANEPall Biomedical Products Co.K855067SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100Cobe Laboratories, Inc.K841958CARDIO METRICS CARDIOTOMY RESERVOIRSterile Design, Inc.K830634CARDIOTOMY FILTERTexas Medical Products, 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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