White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
FDA 510(k) K162448 · Cook Incorporated
510(k) numberK162448
Submission
- Device name
- White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- September 1, 2016
- Decision date
- May 26, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter cleared by the FDA?
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448) received a 510(k) decision of Substantially Equivalent on May 26, 2017, 267 days after the submission was received.
What is the product code of K162448?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.