DPT · Probe, Blood-Flow, Extravascular
Cardiovascular · 21 CFR 870.2120 · Class 2
Overview
| Product Code | DPT |
|---|---|
| Device Name | Probe, Blood-Flow, Extravascular |
| Regulation | 21 CFR 870.2120 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. | May 28, 2024 | SESE |
| K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | Spectralmd, Inc. | Aug 17, 2017 | SESE |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager | Moor Instruments, Ltd. | May 12, 2016 | SESE |
| K142932 | Deltex Medical KDP72 Doppler Probe | Deltex Medical Limited | Jan 22, 2015 | SESE |
| K132730 | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE | Medtronic, Inc. | May 30, 2014 | SESE |
| K133903 | BIO-PROBE TRANSDUCER (ADULT) | Medtronic, Inc. | Apr 10, 2014 | SESE |
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | Jan 29, 2014 | SESE |
| K124049 | DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM | Spectralmd, Inc. | Apr 18, 2013 | SESE |
| K123216 | AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN | Aimago SA | Feb 7, 2013 | SESE |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | Jan 3, 2013 | SESE |
| K121429 | AIMAGO EASYLDI MICROCIRCULATION CAMERA | Aimago SA | Aug 10, 2012 | SESE |
| K120884 | PERICAM PSI | Perimed AB | Jul 3, 2012 | SESE |
| K073593 | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 | Deltex Medical Limited | Jan 29, 2009 | SESE |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | Mar 27, 2007 | SESE |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | Jan 25, 2007 | SESE |
| K063561 | MOORLDLS LASER DOPPLER LINE SCANNER | Moor Instruments, Ltd. | Jan 19, 2007 | SESE |
| K052989 | DP240 240 HOUR DOPPLER PROBE | Deltex Medical | Mar 8, 2006 | SESE |
| K032841 | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR | Moor Instruments, Ltd. | Dec 10, 2003 | SESE |
| K013939 | JOSTRA FLOWPROBE FP-32E | Jostra AG | Dec 14, 2001 | SESE |
| K012747 | TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) | Medtronic Perfusion Systems | Sep 14, 2001 | SESE |
Top Applicants
- Moor Instruments, Ltd. — 8 clearances
- Hewlett-Packard Co. — 3 clearances
- Vasamedics, LLC — 3 clearances
- Aimago SA — 2 clearances
- Deltex Medical Limited — 2 clearances
