R2P Destination Slender Guiding Sheath
FDA 510(k) K193125 · Terumo Medical Corporation
510(k) numberK193125
Submission
- Device name
- R2P Destination Slender Guiding Sheath
- Applicant
- Terumo Medical Corporation
Elkton, MD, US - Received
- November 12, 2019
- Decision date
- January 6, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
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| K231044 | R2P NavicrossDQY · Traditional | 07/27/2023SE |
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | 12/20/2021SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | 08/03/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination…DYB · Traditional | 11/21/2017SE |
| K171491 | R2P Destination Slender Guiding SheathDYB · Traditional | 10/05/2017SE |
| K152173 | GlidesheathDYB · Traditional | 12/01/2015SE |
| K152525 | TR BAND Radial Compression DeviceDXC · Traditional | 11/10/2015SE |
| K151471 | Radifocus Glidewire Endoscopic WireOCY · Traditional | 09/17/2015SE |
| K142183 | Glidesheath SlenderDYB · Special | 11/21/2014SE |
Questions and answers
When was R2P Destination Slender Guiding Sheath cleared by the FDA?
R2P Destination Slender Guiding Sheath (K193125) received a 510(k) decision of Substantially Equivalent on January 6, 2020, 55 days after the submission was received.
What is the product code of K193125?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.