Modification to Supercross Catheter
FDA 510(k) K014118 · Abbott Vascular, Inc.
510(k) numberK014118
Submission
- Device name
- Modification to Supercross Catheter
- Applicant
- Abbott Vascular, Inc.
Redwood, CA, US - Received
- December 14, 2001
- Decision date
- January 11, 2002
- 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 Modification to Supercross Catheter cleared by the FDA?
Modification to Supercross Catheter (K014118) received a 510(k) decision of Substantially Equivalent on January 11, 2002, 28 days after the submission was received.
What is the product code of K014118?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.