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FDA 510(k)

SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE

K-Number: K855064 · 1986-03-12

ApplicantCobe Laboratories, Inc.
Decision Date1986-03-12
Product CodeCAK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE 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 1986-03-12 under 510(k) number K855064. The device is classified under product code CAK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE?

SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K855064.

When did SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE receive FDA 510(k) clearance?

SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE received FDA 510(k) clearance on 1986-03-12, under 510(k) number K855064.

Who is the listed applicant for SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE?

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 BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE?

The FDA product code for SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE is CAK.

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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: CAK)

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.

K061103HAEMONETICS 40U RBC FILTER BAGHaemonetics Corp.K022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETSummit Medical , Ltd.K000719NEOCARE 20 MICRON BLOOD FILTERWhatman, Inc.K990310CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)Charter Medical, Ltd.K982822FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72Baxter Healthcare CorpK972159FENWAL 40 MICRON TRANSFUSION FILTERBaxter Healthcare Corp

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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