FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
K Number: K083814
·
Decision Jan 13, 2009
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
5
Review Days
22
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
- OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
- K Number
- K083814
- 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
- December 22, 2008
- Decision Date
- January 13, 2009
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PDU), ordered by most recent decision date.
Santreva-ATK Endovascular Revasculariztion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire® 14 Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
LimFlow ARC
FDA 510(k)
FDA Class 2
·Cardiovascular
PowerWire Radiofrequency Guidewire Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
SoundBite® Crossing System XS Peripheral
FDA 510(k)
FDA Class 2
·Cardiovascular
Tigereye ST CTO-Crossing Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Cordis Corp., A Johnson & Johnson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K140438 | MICRO GUIDE CATHETER ELITE | Nov 14, 2014 | Substantially Equivalent |
| K131225 | ADROIT GUIDING CATHETER | May 29, 2013 | Substantially Equivalent |
| K091077 | OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER | Feb 4, 2010 | Substantially Equivalent |
| K062531 | ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE | Sep 22, 2006 | Substantially Equivalent |