Veripath Peripheral Guiding Catheter
FDA 510(k) K994229 · Advanced Cardiovascular Systems, Inc.
510(k) numberK994229
Submission
- Device name
- Veripath Peripheral Guiding Catheter
- Applicant
- Advanced Cardiovascular Systems, Inc.
Temecula, CA, US - Received
- December 16, 1999
- Decision date
- February 25, 2000
- 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 Veripath Peripheral Guiding Catheter cleared by the FDA?
Veripath Peripheral Guiding Catheter (K994229) received a 510(k) decision of Substantially Equivalent on February 25, 2000, 71 days after the submission was received.
What is the product code of K994229?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.