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FDA 510(k)

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)

K-Number: K964989 · 1997-04-02

ApplicantCritical Device Corp.
Decision Date1997-04-02
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) is the device name listed in this FDA 510(k) record. The listed applicant is Critical Device Corp.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K964989. 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 CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)?

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Critical Device Corp.. The 510(k) number is K964989.

When did CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) receive FDA 510(k) clearance?

CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) received FDA 510(k) clearance on 1997-04-02, under 510(k) number K964989.

Who is the listed applicant for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)?

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

What is the FDA product code for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)?

The FDA product code for CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) is LHI.

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 Critical Device Corp. 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.

K983926MPS GRAVITY FLOW CONTROL SETK964918NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETSK964812NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SETK952852NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SETK955896MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

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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