FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
K Number: K972793
·
Decision Apr 24, 1998
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
24
Review Days
270
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
- PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE
- K Number
- K972793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radi Medical Systems AB
- Date Received
- July 28, 1997
- Decision Date
- April 24, 1998
- 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 Radi Medical Systems AB
| K Number | Device Name | ||
|---|---|---|---|
| K123984 | QUANTIEN MEASUREMENT SYSTEM | Mar 28, 2013 | Substantially Equivalent |
| K092105 | RADIANALYZER XPRESS | Oct 9, 2009 | Substantially Equivalent |
| K080813 | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER | Jul 1, 2008 | Substantially Equivalent |
| K080206 | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM | Feb 26, 2008 | Substantially Equivalent |
| K062769 | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 | Dec 4, 2006 | Substantially Equivalent |
| K042628 | MODIFICATION TO: RADIANALYZER, MODEL 12711 | Jan 19, 2005 | Substantially Equivalent |
| K033291 | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 | Mar 17, 2004 | Substantially Equivalent |
| K031662 | PRESSURE WIRE SENSOR, MODELS 12004/12304 | Jun 6, 2003 | Substantially Equivalent |
| K024107 | FEMOSTOP FEMORAL COMPRESSION SYSTEM | Dec 24, 2002 | Substantially Equivalent |
| K022188 | RADIANALYZER, MODEL 12710 | Oct 3, 2002 | Substantially Equivalent |