Trailblazer Support Catheter
FDA 510(k) K092299 · Ev3, Inc.
510(k) numberK092299
Submission
- Device name
- Trailblazer Support Catheter
- Applicant
- Ev3, Inc.
Buffalo, MN, US - Received
- July 29, 2009
- Decision date
- August 7, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Trailblazer Support Catheter cleared by the FDA?
Trailblazer Support Catheter (K092299) received a 510(k) decision of Substantially Equivalent on August 7, 2009, 9 days after the submission was received.
What is the product code of K092299?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.