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FDA 510(k)

PALL EC PLUS FILTER W/FILTER SLEEVE

K-Number: K834382 · 1984-08-03

ApplicantPall Biomedical Products Co.
Decision Date1984-08-03
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PALL EC PLUS FILTER W/FILTER SLEEVE 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 1984-08-03 under 510(k) number K834382. 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 PALL EC PLUS FILTER W/FILTER SLEEVE?

PALL EC PLUS FILTER W/FILTER SLEEVE is a medical device that received FDA 510(k) clearance on 1984-08-03. The listed applicant is Pall Biomedical Products Co.. The 510(k) number is K834382.

When did PALL EC PLUS FILTER W/FILTER SLEEVE receive FDA 510(k) clearance?

PALL EC PLUS FILTER W/FILTER SLEEVE received FDA 510(k) clearance on 1984-08-03, under 510(k) number K834382.

Who is the listed applicant for PALL EC PLUS FILTER W/FILTER SLEEVE?

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 EC PLUS FILTER W/FILTER SLEEVE?

The FDA product code for PALL EC PLUS FILTER W/FILTER SLEEVE is DTM.

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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: 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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