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FDA 510(k)

PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE

K-Number: K855065 · 1986-02-28

ApplicantCobe Laboratories, Inc.
Decision Date1986-02-28
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION 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 1986-02-28 under 510(k) number K855065. The device is classified under product code FPB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE?

PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K855065.

When did PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE receive FDA 510(k) clearance?

PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE received FDA 510(k) clearance on 1986-02-28, under 510(k) number K855065.

Who is the listed applicant for PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION 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 PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE?

The FDA product code for PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE is FPB.

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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: FPB)

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.

K261403Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion FilterGlobal Life Sciences Solutions USA, LLCK233277Filter Needle for Single UseHangzhou Qiantang Longyue Biotechnology Co., Ltd.K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERBaxter Healthcare CorpK021293ARTERIA BLOOD FILTERArteria Medical Science, Inc.K993379PALL SUPOR AEF FILTERPall Corp.K9746610.2 U BACTERIAL FILTERSims Deltec, 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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