FDA 510(k)

3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES

K-Number: K915390 · 1992-03-12

Decision Date1992-03-12

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES 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 1992-03-12 under 510(k) number K915390. 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 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES?

3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES is a medical device that received FDA 510(k) clearance on 1992-03-12. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K915390.

When did 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES receive FDA 510(k) clearance?

3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES received FDA 510(k) clearance on 1992-03-12, under 510(k) number K915390.

Who is the listed applicant for 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES?

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 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES?

The FDA product code for 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES 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.