510(k) K962700
- Device
- VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
- Applicant
- VASAMEDICS, L.L.C.
- 510(k) number
- K962700
- Product code
- DPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-09
- Date received
- 1996-07-12
- Regulation
- 870.2120
- Classification name
- Probe, Blood-flow, Extravascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLAS G TOMASKO
- Address
- 2963 Yorkton Blvd. Saint Paul MN US 55117 55117
FDA Registration Numbers#
- 8043564
- 3013500228
- 1526863
- 9613067
- 1928237
- 3003647374
- 3013596024
- 3012307300
- 3021013124
- 9680933
- 9617601
- 2184009
- 3005941719
- 8030885
- 1422634
- 3008483389
- 9616567
- 2011171
Source Documents#
Other 510(k) Records For Product Code DPT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW) | Rwd Life Science Co., Ltd. | 2024-05-28 |
| K163339 | SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | Spectralmd, Inc. | 2017-08-17 |
| 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. | 2016-05-12 |
| K142932 | Deltex Medical KDP72 Doppler Probe | Deltex Medical Limited | 2015-01-22 |
| K132730 | BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE | Medtronic, Inc. | 2014-05-30 |
| K133903 | BIO-PROBE TRANSDUCER (ADULT) | Medtronic, Inc. | 2014-04-10 |
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | 2014-01-29 |
| K124049 | DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM | Spectralmd, Inc. | 2013-04-18 |
| K123216 | AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN | Aimago SA | 2013-02-07 |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | 2013-01-03 |
| K121429 | AIMAGO EASYLDI MICROCIRCULATION CAMERA | Aimago SA | 2012-08-10 |
| K120884 | PERICAM PSI | Perimed AB | 2012-07-03 |
| K073593 | I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-7016 | Deltex Medical Limited | 2009-01-29 |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | Moor Instruments, Ltd. | 2007-03-27 |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | Moor Instruments, Ltd. | 2007-01-25 |
Legacy Summary#
summary
FDA Review#
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