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FDA 510(k)

MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11

K-Number: K955896 · 1996-02-06

ApplicantCritical Device Corp.
Decision Date1996-02-06
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 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 1996-02-06 under 510(k) number K955896. 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 MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11?

MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 is a medical device that received FDA 510(k) clearance on 1996-02-06. The listed applicant is Critical Device Corp.. The 510(k) number is K955896.

When did MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 receive FDA 510(k) clearance?

MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 received FDA 510(k) clearance on 1996-02-06, under 510(k) number K955896.

Who is the listed applicant for MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11?

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 MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11?

The FDA product code for MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 is LHI.

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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. SETSK964989CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)K964812NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SETK952852NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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