Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
FDA 510(k) K172995 · Terumo Medical Corporation
510(k) numberK172995
Submission
- Device name
- Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
- Applicant
- Terumo Medical Corporation
Elkton, MD, US - Received
- September 27, 2017
- Decision date
- November 21, 2017
- 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 |
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| K193125 | R2P Destination Slender Guiding SheathDYB · Traditional | 01/06/2020SE |
| K181237 | Glidesheath Slender Tibial Pedal KitDYB · Traditional | 08/03/2018SE |
| K173831 | Glidesheath SlenderDYB · Traditional | 05/08/2018SE |
| 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 Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath cleared by the FDA?
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath (K172995) received a 510(k) decision of Substantially Equivalent on November 21, 2017, 55 days after the submission was received.
What is the product code of K172995?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.