Agiltrac .018 Peripheral Dilatation Catheter
FDA 510(k) K020161 · Guidant Corp.
510(k) numberK020161
Submission
- Device name
- Agiltrac .018 Peripheral Dilatation Catheter
- Applicant
- Guidant Corp.
Santa Clara, CA, US - Received
- January 17, 2002
- Decision date
- February 22, 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 Agiltrac .018 Peripheral Dilatation Catheter cleared by the FDA?
Agiltrac .018 Peripheral Dilatation Catheter (K020161) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 36 days after the submission was received.
What is the product code of K020161?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.