Outback Ltd Re-Entry Catheter, Model: OTB42120
FDA 510(k) K083814 · Cordis Corp., A Johnson & Johnson Co.
510(k) numberK083814
Submission
- Device name
- Outback Ltd Re-Entry Catheter, Model: OTB42120
- Applicant
- Cordis Corp., A Johnson & Johnson Co.
Warren, NJ, US - Received
- December 22, 2008
- Decision date
- January 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
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Questions and answers
When was Outback Ltd Re-Entry Catheter, Model: OTB42120 cleared by the FDA?
Outback Ltd Re-Entry Catheter, Model: OTB42120 (K083814) received a 510(k) decision of Substantially Equivalent on January 13, 2009, 22 days after the submission was received.
What is the product code of K083814?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.