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FDA 510(k)

INTERSEPT* BLOOD FILTER W/ TUBING BYPASS

K-Number: K790435 · 1979-03-27

ApplicantSurgikos, Inc.
Decision Date1979-03-27
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERSEPT* BLOOD FILTER W/ TUBING BYPASS is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-03-27 under 510(k) number K790435. 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* BLOOD FILTER W/ TUBING BYPASS?

INTERSEPT* BLOOD FILTER W/ TUBING BYPASS is a medical device that received FDA 510(k) clearance on 1979-03-27. The listed applicant is Surgikos, Inc.. The 510(k) number is K790435.

When did INTERSEPT* BLOOD FILTER W/ TUBING BYPASS receive FDA 510(k) clearance?

INTERSEPT* BLOOD FILTER W/ TUBING BYPASS received FDA 510(k) clearance on 1979-03-27, under 510(k) number K790435.

Who is the listed applicant for INTERSEPT* BLOOD FILTER W/ TUBING BYPASS?

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

What is the FDA product code for INTERSEPT* BLOOD FILTER W/ TUBING BYPASS?

The FDA product code for INTERSEPT* BLOOD FILTER W/ TUBING BYPASS is DTM.

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Other records listing Surgikos, 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.

K875107HEALTH CARE EYE PROTECTIONK874653STERILE SURGICAL SCRUB BRUSHK861441NEUTRALON SURGICAL GLOVESK852870BARRIER SURGICAL GOWNK822535CIDEX*DIALYZER DISINFECTING SOLUTIONK820543BARRIER ANTIMICROBIAL INCISE DRAPE

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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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