Cook-Swartz Doppler Flow Probe
FDA 510(k) K022649 · Cook Vascular, Inc.
510(k) numberK022649
Submission
- Device name
- Cook-Swartz Doppler Flow Probe
- Applicant
- Cook Vascular, Inc.
Leechburg, PA, US - Received
- August 9, 2002
- Decision date
- September 6, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Cook-Swartz Doppler Flow Probe cleared by the FDA?
Cook-Swartz Doppler Flow Probe (K022649) received a 510(k) decision of Substantially Equivalent on September 6, 2002, 28 days after the submission was received.
What is the product code of K022649?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.