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FDA 510(k)

SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K-Number: K090917 · 2010-02-19

ApplicantBaxa Corp.
Decision Date2010-02-19
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K090917. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Baxa Corp.. The 510(k) number is K090917.

When did SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM receive FDA 510(k) clearance?

SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM received FDA 510(k) clearance on 2010-02-19, under 510(k) number K090917.

Who is the listed applicant for SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

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

What is the FDA product code for SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

The FDA product code for SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is LHI.

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Other records listing Baxa Corp. as applicant

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K070163SWABBABLE CAP, MODEL 60205K062909REPEATER PUMP II TUBE SETSK022523RAPID-FILL TUBESET, MODEL 90005K002705EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400K983321MICROFUSE DUAL RATE INFUSERK951871PISTON SYRINGE

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Related Devices (Code: LHI)

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.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)Microtek Medical, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

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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