FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
K Number: K073162
·
Decision Feb 8, 2008
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
6
Review Days
91
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
- SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
- K Number
- K073162
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kensey Nash Corporation
- Date Received
- November 9, 2007
- Decision Date
- February 8, 2008
- 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 Kensey Nash Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K121310 | MESOTHELIUM DENTAL MEMBRANE | Jul 11, 2013 | Substantially Equivalent |
| K112888 | MESO WOUND MATRIX | Feb 10, 2012 | Substantially Equivalent |
| K094061 | KENSEY NASH ECM SURGICAL PATCH | May 18, 2010 | Substantially Equivalent |
| K060917 | KENSEY NASH BONE VOID FILLER | Sep 22, 2006 | Substantially Equivalent |
| K061030 | BIOBLANKET SURGICAL MESH | May 9, 2006 | Substantially Equivalent |