Valet Micro Catheter
FDA 510(k) K112035 · Volcano Corporation
510(k) numberK112035
Submission
- Device name
- Valet Micro Catheter
- Applicant
- Volcano Corporation
Billerica, MA, US - Received
- July 15, 2011
- Decision date
- January 5, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Valet Micro Catheter cleared by the FDA?
Valet Micro Catheter (K112035) received a 510(k) decision of Substantially Equivalent on January 5, 2012, 174 days after the submission was received.
What is the product code of K112035?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.