R2P Navicross
FDA 510(k) K231044 · Terumo Medical Corporation
510(k) numberK231044
Submission
- Device name
- R2P Navicross
- Applicant
- Terumo Medical Corporation
Elkton, MD, US - Received
- April 12, 2023
- Decision date
- July 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K213531 | TR BAND Radial Compression DeviceDXC · Traditional | 12/20/2021SE |
| 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 |
| 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 Navicross cleared by the FDA?
R2P Navicross (K231044) received a 510(k) decision of Substantially Equivalent on July 27, 2023, 106 days after the submission was received.
What is the product code of K231044?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.