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FDA 510(k)

INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT

K-Number: K823108 · 1982-11-30

ApplicantExtracorporeal Medical Specialities, Inc.
Decision Date1982-11-30
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1982-11-30 under 510(k) number K823108. 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 INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT?

INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT is a medical device that received FDA 510(k) clearance on 1982-11-30. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K823108.

When did INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT receive FDA 510(k) clearance?

INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT received FDA 510(k) clearance on 1982-11-30, under 510(k) number K823108.

Who is the listed applicant for INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT?

The FDA 510(k) record lists Extracorporeal Medical Specialities, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT?

The FDA product code for INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT is DTM.

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Other records listing Extracorporeal Medical Specialities, 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.

K843955EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATORK840262HANCOCK PERICARDIAL PATCHK840532HEMOPERFUSION SYSTEM TP-400K840057EXP* 500 PARALLEL PLATE DIALYZERK840146EXP* 700 PARALLEL PLATE DIALYZERK832547ULTRAFILTRATION CONTROLLER

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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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