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FDA 510(k)

SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100

K-Number: K855067 · 1986-02-26

ApplicantCobe Laboratories, Inc.
Decision Date1986-02-26
Product CodeJOD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 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 1986-02-26 under 510(k) number K855067. 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 SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100?

SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K855067.

When did SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 receive FDA 510(k) clearance?

SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 received FDA 510(k) clearance on 1986-02-26, under 510(k) number K855067.

Who is the listed applicant for SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100?

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 SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100?

The FDA product code for SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 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.K841958CARDIO METRICS CARDIOTOMY RESERVOIRSterile Design, Inc.K830634CARDIOTOMY FILTERTexas 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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