FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TXM Hydrophilic Guidewire
K Number: K170915
·
Decision Nov 21, 2017
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
7
Review Days
238
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Basic Information
- Device Name
- TXM Hydrophilic Guidewire
- K Number
- K170915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Texasmedical Technologies, Inc.
- Date Received
- March 28, 2017
- Decision Date
- November 21, 2017
- 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 Texasmedical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K170914 | TXM Support Catheter | Nov 21, 2017 | Substantially Equivalent |
| K153771 | TXM Guiding Sheath | Sep 13, 2016 | Substantially Equivalent |
| K153703 | Guiding Catheter | May 12, 2016 | Substantially Equivalent |
| K153125 | IntraNovo Microcatheter | Jan 13, 2016 | Substantially Equivalent |
| K142954 | PTA 14 Balloon Dilatation Catheter OTW | May 28, 2015 | Substantially Equivalent |
| K142817 | IntraNovo 25 Microcatheter | Apr 23, 2015 | Substantially Equivalent |