FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRO GUIDE CATHETER ELITE
K Number: K140438
·
Decision Nov 14, 2014
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
5
Review Days
266
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Basic Information
- Device Name
- MICRO GUIDE CATHETER ELITE
- K Number
- K140438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cordis Corp., A Johnson & Johnson Co.
- Date Received
- February 21, 2014
- Decision Date
- November 14, 2014
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Cordis Corp., A Johnson & Johnson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K131225 | ADROIT GUIDING CATHETER | May 29, 2013 | Substantially Equivalent |
| K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER | Feb 4, 2010 | Substantially Equivalent |
| K083814 | OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 | Jan 13, 2009 | Substantially Equivalent |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Sep 22, 2006 | Substantially Equivalent |