Crosser Recanalization System
FDA 510(k) K112308 · C.R. Bard, Inc.
510(k) numberK112308
Submission
- Device name
- Crosser Recanalization System
- Applicant
- C.R. Bard, Inc.
Sunnyvale, CA, US - Received
- August 11, 2011
- Decision date
- August 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Crosser Recanalization System cleared by the FDA?
Crosser Recanalization System (K112308) received a 510(k) decision of Substantially Equivalent on August 17, 2011, 6 days after the submission was received.
What is the product code of K112308?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.