Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta Catheter
FDA 510(k) K090509 · Abbott Vascular-Vascular Solutions
510(k) numberK090509
Submission
- Device name
- Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta Catheter
- Applicant
- Abbott Vascular-Vascular Solutions
Santa Clara, CA, US - Received
- February 26, 2009
- Decision date
- March 20, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta Catheter cleared by the FDA?
Foxcross .035 Pta Catheter 14 MM X 20MM X 80 CM, Model 10342-20, Foxcross .035 Pta Catheter (K090509) received a 510(k) decision of Substantially Equivalent on March 20, 2009, 22 days after the submission was received.
What is the product code of K090509?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.