FDA 510(k)

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE

K-Number: K042936 · 2004-11-26

Decision Date2004-11-26

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 2004-11-26 under 510(k) number K042936. 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 SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE?

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE is a medical device that received FDA 510(k) clearance on 2004-11-26. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K042936.

When did SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE receive FDA 510(k) clearance?

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE received FDA 510(k) clearance on 2004-11-26, under 510(k) number K042936.

Who is the listed applicant for SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE?

The FDA product code for SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE is FPA.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Baxter Healthcare Corp as applicant

K190910PrisMax System Version 2 K163530PrisMax Control Unit K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO K123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

View all 504 devices →

Related Devices (Code: FPA)

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC K261530iiSure Infusion SetDeka Research and Development K252543AMSafe 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 Medical K250325BD 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.