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FDA 510(k)

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE

K-Number: K020365 · 2002-05-03

Applicant3t Medical Systems, LLC
Decision Date2002-05-03
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE 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 2002-05-03 under 510(k) number K020365. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE?

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 2002-05-03. The listed applicant is 3t Medical Systems, LLC. The 510(k) number is K020365.

When did 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE receive FDA 510(k) clearance?

3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE received FDA 510(k) clearance on 2002-05-03, under 510(k) number K020365.

Who is the listed applicant for 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE?

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 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE?

The FDA product code for 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE is KRI.

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 CANNULASK0012453T L. V. CONTROL VALVE

Related Devices (Code: KRI)

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.

K992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, Inc.K892856NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERSAcacia Laboratories, 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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