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FDA 510(k)

EXTRACORPEAL CARDIOTOMY BLOOD FILTER

K-Number: K780653 · 1978-06-14

ApplicantCobe Laboratories, Inc.
Decision Date1978-06-14
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRACORPEAL CARDIOTOMY BLOOD FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-14 under 510(k) number K780653. 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 EXTRACORPEAL CARDIOTOMY BLOOD FILTER?

EXTRACORPEAL CARDIOTOMY BLOOD FILTER is a medical device that received FDA 510(k) clearance on 1978-06-14. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K780653.

When did EXTRACORPEAL CARDIOTOMY BLOOD FILTER receive FDA 510(k) clearance?

EXTRACORPEAL CARDIOTOMY BLOOD FILTER received FDA 510(k) clearance on 1978-06-14, under 510(k) number K780653.

Who is the listed applicant for EXTRACORPEAL CARDIOTOMY BLOOD FILTER?

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

What is the FDA product code for EXTRACORPEAL CARDIOTOMY BLOOD FILTER?

The FDA product code for EXTRACORPEAL CARDIOTOMY BLOOD FILTER is JOD.

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Other records listing Cobe Laboratories, 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.

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATORK900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTICK905793COBE CENTRY 2 BICART OPTION KITK905388COBE CENTRYSYSTEM 3 BICART OPTION KITK904336NEW COBE SATURATION/HEMATOCRIT MONITORK902631COBE ICU CONVERSION KIT

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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.K874405PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USEPall Biomedical Products Co.K855067SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100Cobe Laboratories, Inc.K841958CARDIO METRICS CARDIOTOMY RESERVOIRSterile Design, 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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