3TM Myocardial Needle-Temperature Probe
FDA 510(k) K020365 · 3t Medical Systems, LLC
510(k) numberK020365
Submission
- Device name
- 3TM Myocardial Needle-Temperature Probe
- Applicant
- 3t Medical Systems, LLC
Conifer, CO, US - Received
- February 4, 2002
- Decision date
- May 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KRI – Accessory Equipment, Cardiopulmonary Bypass
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4200
- Specialty
- Cardiovascular
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| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | American Omni Medical, Inc. | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | American Omni Medical, Inc. | 01/24/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
| K874925 | Cpe 2000 Cardio Pulmonary ErgometerKRI · Traditional | Medical Graphics Corp. | 01/19/1988SE |
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| K020768 | 3T Vessel CannulasDWF · Traditional | 08/23/2002SE |
| K001245 | 3T L. V. Control ValveMJJ · Traditional | 08/15/2001SE |
Questions and answers
When was 3TM Myocardial Needle-Temperature Probe cleared by the FDA?
3TM Myocardial Needle-Temperature Probe (K020365) received a 510(k) decision of Substantially Equivalent on May 3, 2002, 88 days after the submission was received.
What is the product code of K020365?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.