Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit
FDA 510(k) K962700 · Vasamedics, LLC
510(k) numberK962700
Submission
- Device name
- Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit
- Applicant
- Vasamedics, LLC
Saint Paul, MN, US - Received
- July 12, 1996
- Decision date
- April 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
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| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | Deltex Medical Limited | 01/22/2015SE |
| K132730 | Bio-Probe Disposable Insert with; Balance Biosurface, Carmeda Bioactive Surface…DPT · Traditional | Medtronic, Inc. | 05/30/2014SE |
| K133903 | Bio-Probe Transducer (Adult)DPT · Traditional | Medtronic, Inc. | 04/10/2014SE |
| K132163 | Moorldls-Bi Laser Doppler Burns ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/29/2014SE |
| K124049 | Deepview Digital Video Physiological Portable Imaging SystemDPT · Traditional | Spectralmd, Inc. | 04/18/2013SE |
| K123216 | Aimago Easyldi Microcirculation Camera (Stand Plus Camera Arm), Aimago Easy Ldi Stand…DPT · Traditional | Aimago SA | 02/07/2013SE |
| K122943 | MOORFLPI-2 Full-Field Laser Perfusion ImagerDPT · Traditional | Moor Instruments, Ltd. | 01/03/2013SE |
More from Moor Instruments, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe KitDPT · Traditional | 10/11/1996SESK |
| K951832 | Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433DPT · Traditional | 03/21/1996SE |
| K951486 | Model PV2000 Vascular MicrolaboratoryDPW · Traditional | 06/29/1995SE |
| K912446 | Modif. Laserflo Blood Perfusion Monitor Model BPM2DPW · Traditional | 12/12/1991SE |
| K911763 | Laserflo(R) Blood Perfusion Monitor (Model BPM2)DPW · Traditional | 08/13/1991SE |
Questions and answers
When was Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit cleared by the FDA?
Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit (K962700) received a 510(k) decision of Substantially Equivalent on April 9, 1997, 271 days after the submission was received.
What is the product code of K962700?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.