Viking Optima Guiding Catheter
FDA 510(k) K012002 · Guidant Corp.
510(k) numberK012002
Submission
- Device name
- Viking Optima Guiding Catheter
- Applicant
- Guidant Corp.
Temecula, CA, US - Received
- June 27, 2001
- Decision date
- July 26, 2001
- 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 Viking Optima Guiding Catheter cleared by the FDA?
Viking Optima Guiding Catheter (K012002) received a 510(k) decision of Substantially Equivalent on July 26, 2001, 29 days after the submission was received.
What is the product code of K012002?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.