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FDA 510(k)

CMS IV EXTENSION SETS

K-Number: K884370 · 1988-11-07

ApplicantChurchill Medical Systems, Inc.
Decision Date1988-11-07
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CMS IV EXTENSION SETS 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 1988-11-07 under 510(k) number K884370. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMS IV EXTENSION SETS?

CMS IV EXTENSION SETS is a medical device that received FDA 510(k) clearance on 1988-11-07. The listed applicant is Churchill Medical Systems, Inc.. The 510(k) number is K884370.

When did CMS IV EXTENSION SETS receive FDA 510(k) clearance?

CMS IV EXTENSION SETS received FDA 510(k) clearance on 1988-11-07, under 510(k) number K884370.

Who is the listed applicant for CMS IV EXTENSION SETS?

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 CMS IV EXTENSION SETS?

The FDA product code for CMS IV EXTENSION SETS is FPK.

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: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, 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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