FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R2P Navicross
K Number: K231044
·
Decision Jul 27, 2023
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
14
Review Days
106
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Basic Information
- Device Name
- R2P Navicross
- K Number
- K231044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Medical Corporation
- Date Received
- April 12, 2023
- Decision Date
- July 27, 2023
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Terumo Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K213531 | TR BAND Radial Compression Device | Dec 20, 2021 | Substantially Equivalent |
| K193125 | R2P Destination Slender Guiding Sheath | Jan 6, 2020 | Substantially Equivalent |
| K181237 | Glidesheath Slender Tibial Pedal Kit | Aug 3, 2018 | Substantially Equivalent |
| K173831 | Glidesheath Slender | May 8, 2018 | Substantially Equivalent |
| K172995 | Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath | Nov 21, 2017 | Substantially Equivalent |
| K171491 | R2P Destination Slender Guiding Sheath | Oct 5, 2017 | Substantially Equivalent |
| K152173 | Glidesheath | Dec 1, 2015 | Substantially Equivalent |
| K152525 | TR BAND Radial Compression Device | Nov 10, 2015 | Substantially Equivalent |
| K151471 | Radifocus Glidewire Endoscopic Wire | Sep 17, 2015 | Substantially Equivalent |
| K142183 | GLIDESHEATH SLENDER | Nov 21, 2014 | Substantially Equivalent |