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FDA 510(k)

3T L. V. CONTROL VALVE

K-Number: K001245 · 2001-08-15

Applicant3t Medical Systems, LLC
Decision Date2001-08-15
Product CodeMJJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3T L. V. CONTROL VALVE is the device name listed in this FDA 510(k) record. The listed applicant is 3t Medical Systems, LLC. It received FDA 510(k) clearance on 2001-08-15 under 510(k) number K001245. The device is classified under product code MJJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3T L. V. CONTROL VALVE?

3T L. V. CONTROL VALVE is a medical device that received FDA 510(k) clearance on 2001-08-15. The listed applicant is 3t Medical Systems, LLC. The 510(k) number is K001245.

When did 3T L. V. CONTROL VALVE receive FDA 510(k) clearance?

3T L. V. CONTROL VALVE received FDA 510(k) clearance on 2001-08-15, under 510(k) number K001245.

Who is the listed applicant for 3T L. V. CONTROL VALVE?

The FDA 510(k) record lists 3t Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3T L. V. CONTROL VALVE?

The FDA product code for 3T L. V. CONTROL VALVE is MJJ.

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 3t Medical Systems, LLC 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.

K0726973T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIESK0222873T/SEWOON TEMPERATURE SENSING FOLEY CATHETERSK0207683T VESSEL CANNULASK0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

Related Devices (Code: MJJ)

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.

K182442MiniGuard Arterial Safety ValveQuest Medical, Inc.K992785IBC FLOGUARD, MODEL 6050International Biophysics Corp.K982406COBE VACUUM RELIEF CHECK VALVECobe Cardiovascular, Inc.K960937SUCTION SAFETY DEVICER D Intl.K922781FLOW CONROL VALVEAmerican Omni Medical, Inc.K922356FLOW CONTROL VALVE, CAT. NO. ACV-38American Omni Medical, Inc.

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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