Arterial Canalization Device
FDA 510(k) K820516 · Alimed, Inc.
510(k) numberK820516
Submission
- Device name
- Arterial Canalization Device
- Applicant
- Alimed, Inc.
Walker, MI, US - Received
- February 25, 1982
- Decision date
- April 15, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Arterial Canalization Device cleared by the FDA?
Arterial Canalization Device (K820516) received a 510(k) decision of Substantially Equivalent on April 15, 1982, 49 days after the submission was received.
What is the product code of K820516?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.