FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCUPUNCTURE PICC GUIDEWIRE
K Number: K031652
·
Decision Sep 30, 2003
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
21
Review Days
125
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Basic Information
- Device Name
- VASCUPUNCTURE PICC GUIDEWIRE
- K Number
- K031652
- 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
- May 28, 2003
- Decision Date
- September 30, 2003
- 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 |
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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 |
| K101729 | NEOWIRE PTA/PTCA GUIDEWIRE | Sep 23, 2010 | 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 |