FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K Number: K122590
·
Decision Mar 1, 2013
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
14
Review Days
189
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
- K Number
- K122590
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terumo Medical Corporation
- Date Received
- August 24, 2012
- Decision Date
- March 1, 2013
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQX), ordered by most recent decision date.
InQwire Amplatz Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
FDA 510(k)
FDA Class 2
·Cardiovascular
Enroute 0.014'' Transcarotid Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
EmeryGlide (EG18008901)
FDA 510(k)
FDA Class 2
·Cardiovascular
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
FDA 510(k)
FDA Class 2
·Cardiovascular
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Terumo Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K231044 | R2P Navicross | Jul 27, 2023 | Substantially Equivalent |
| 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 |