Jostra Flowprobe FP-32E
FDA 510(k) K013939 · Jostra AG
510(k) numberK013939
Submission
- Device name
- Jostra Flowprobe FP-32E
- Applicant
- Jostra AG
Oxford, PA, US - Received
- November 29, 2001
- Decision date
- December 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
Other 510(k)s with product code DPT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233076 | Laser Speckle Imaging System (RFLSI CZW)DPT · Traditional | Rwd Life Science Co., Ltd. | 05/28/2024SE |
| K163339 | Spectralmd Deepview Wound Imaging System 2.0DPT · Traditional | Spectralmd, Inc. | 08/17/2017SE |
| K152749 | moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser…DPT · Traditional | Moor Instruments, Ltd. | 05/12/2016SE |
| 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 |
|---|---|---|
| K020983 | Jostra Suckers, Model JSDWF · Traditional | 01/30/2004SE |
| K031544 | Heater Cooler Unit, Model Hcu 30DWC · Traditional | 08/07/2003SE |
| K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030DTZ · Special | 02/26/2003SE |
| K020784 | Jostra Single Stage Venous Return CathetersDWF · Traditional | 01/09/2003SE |
| K023132 | Jostra Mecc SystemKFM · Traditional | 12/17/2002SE |
| K022022 | Jostra Vent Catheters, Models LV & HKVDWF · Traditional | 09/11/2002SE |
| K020515 | Jostra Antegrade Cardioplegia CannulaDWF · Traditional | 04/24/2002SE |
| K014303 | Jostra Retrograde Cardioplegia CannulaeDWF · Traditional | 03/26/2002SE |
| K013944 | Jostra Dual Stage Venous Return CannulaeDWF · Traditional | 02/11/2002SE |
| K012774 | Jostra Arterial Perfusion CannulaeDWF · Traditional | 11/16/2001SE |
Questions and answers
When was Jostra Flowprobe FP-32E cleared by the FDA?
Jostra Flowprobe FP-32E (K013939) received a 510(k) decision of Substantially Equivalent on December 14, 2001, 15 days after the submission was received.
What is the product code of K013939?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.