FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K Number: K022357
·
Decision Oct 16, 2002
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
19
Review Days
89
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
- TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
- K Number
- K022357
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific, Target
- Date Received
- July 19, 2002
- Decision Date
- October 16, 2002
- 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 Boston Scientific, Target
| K Number | Device Name | ||
|---|---|---|---|
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | Aug 1, 2003 | Substantially Equivalent |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | May 14, 2003 | Substantially Equivalent |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | Mar 14, 2003 | Substantially Equivalent |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Nov 21, 2002 | Substantially Equivalent |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | Jun 6, 2002 | Substantially Equivalent |
| K014109 | IN-TIME RETRIEVAL DEVICE | Mar 12, 2002 | Substantially Equivalent |
| K012985 | MATRIX DETACHABLE COILS | Jan 31, 2002 | Substantially Equivalent |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | Dec 6, 2001 | Substantially Equivalent |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | Apr 18, 2001 | Substantially Equivalent |
| K010707 | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 | Mar 29, 2001 | Substantially Equivalent |