FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOWIRE PTA/PTCA GUIDEWIRE
K Number: K101729
·
Decision Sep 23, 2010
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
21
Review Days
94
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
- NEOWIRE PTA/PTCA GUIDEWIRE
- K Number
- K101729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neometrics, Inc.
- Date Received
- June 21, 2010
- Decision Date
- September 23, 2010
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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 Neometrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152560 | Bard Snare Retrieval Kit | Oct 23, 2015 | Substantially Equivalent |
| K150225 | NovaGold High Performance Guidewire | Mar 16, 2015 | Substantially Equivalent |
| K143135 | Spring Coil Guidewire | Feb 20, 2015 | Substantially Equivalent |
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE | Feb 20, 2014 | Substantially Equivalent |
| K123439 | NEO ERCP GUIDEWIRE | Jan 3, 2013 | Substantially Equivalent |
| K070150 | VASCUPUNCTURE PICC GUIDEWIRE | Feb 15, 2007 | Substantially Equivalent |
| K043398 | MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE | Mar 1, 2005 | Substantially Equivalent |
| K040786 | VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING | Apr 19, 2004 | Substantially Equivalent |
| K033321 | SELECTIVA SB GUIDEWIRE | Nov 5, 2003 | Substantially Equivalent |
| K031652 | VASCUPUNCTURE PICC GUIDEWIRE | Sep 30, 2003 | Substantially Equivalent |