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FDA 510(k)

FILTER, EXTRACORPOREAL BLOOD HOLDER

K-Number: K781861 · 1978-11-15

ApplicantSurgikos, Inc.
Decision Date1978-11-15
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FILTER, EXTRACORPOREAL BLOOD HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1978-11-15 under 510(k) number K781861. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILTER, EXTRACORPOREAL BLOOD HOLDER?

FILTER, EXTRACORPOREAL BLOOD HOLDER is a medical device that received FDA 510(k) clearance on 1978-11-15. The listed applicant is Surgikos, Inc.. The 510(k) number is K781861.

When did FILTER, EXTRACORPOREAL BLOOD HOLDER receive FDA 510(k) clearance?

FILTER, EXTRACORPOREAL BLOOD HOLDER received FDA 510(k) clearance on 1978-11-15, under 510(k) number K781861.

Who is the listed applicant for FILTER, EXTRACORPOREAL BLOOD HOLDER?

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 FILTER, EXTRACORPOREAL BLOOD HOLDER?

The FDA product code for FILTER, EXTRACORPOREAL BLOOD HOLDER is KRI.

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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: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia 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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