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FDA 510(k)

.22 & 1.2 MICRON IV FILTERS

K-Number: K894954 · 1989-11-13

ApplicantChurchill Medical Systems, Inc.
Decision Date1989-11-13
Product CodeFPB
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

.22 & 1.2 MICRON IV FILTERS is the device name listed in this FDA 510(k) record. The listed applicant is Churchill Medical Systems, Inc.. It received FDA 510(k) clearance on 1989-11-13 under 510(k) number K894954. 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 .22 & 1.2 MICRON IV FILTERS?

.22 & 1.2 MICRON IV FILTERS is a medical device that received FDA 510(k) clearance on 1989-11-13. The listed applicant is Churchill Medical Systems, Inc.. The 510(k) number is K894954.

When did .22 & 1.2 MICRON IV FILTERS receive FDA 510(k) clearance?

.22 & 1.2 MICRON IV FILTERS received FDA 510(k) clearance on 1989-11-13, under 510(k) number K894954.

Who is the listed applicant for .22 & 1.2 MICRON IV FILTERS?

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

What is the FDA product code for .22 & 1.2 MICRON IV FILTERS?

The FDA product code for .22 & 1.2 MICRON IV FILTERS is FPB.

Related Clinical Trials

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.

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Other records listing Churchill Medical Systems, 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.

K041038CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINERK021395MODIFICATION TO 30 EXTENSION SETK013949UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTORK020544WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GAK013950VENTED VIAL ACCESS DEVICEK012157CHURCHILL MEDICAL SYSTEMS STOPCOCK

View all 12 devices →

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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