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FDA 510(k)

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK

K-Number: K011336 · 2001-06-12

ApplicantChurchill Medical Systems, Inc.
Decision Date2001-06-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK 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 2001-06-12 under 510(k) number K011336. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK?

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Churchill Medical Systems, Inc.. The 510(k) number is K011336.

When did PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK receive FDA 510(k) clearance?

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK received FDA 510(k) clearance on 2001-06-12, under 510(k) number K011336.

Who is the listed applicant for PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK?

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 PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK?

The FDA product code for PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK is FPA.

Related Clinical Trials

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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: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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