ViperCath XC Peripheral Exchange Catheter
FDA 510(k) K211251 · Cardiovascular Systems, Inc.
510(k) numberK211251
Submission
- Device name
- ViperCath XC Peripheral Exchange Catheter
- Applicant
- Cardiovascular Systems, Inc.
St.Paul, MN, US - Received
- April 26, 2021
- Decision date
- May 26, 2021
- 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 ViperCath XC Peripheral Exchange Catheter cleared by the FDA?
ViperCath XC Peripheral Exchange Catheter (K211251) received a 510(k) decision of Substantially Equivalent on May 26, 2021, 30 days after the submission was received.
What is the product code of K211251?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.