Percupass Tunneling Tool Model 3452
FDA 510(k) K772013 · Medtronic Vascular
510(k) numberK772013
Submission
- Device name
- Percupass Tunneling Tool Model 3452
- Applicant
- Medtronic Vascular
Walker, MI, US - Received
- October 25, 1977
- Decision date
- October 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Percupass Tunneling Tool Model 3452 cleared by the FDA?
Percupass Tunneling Tool Model 3452 (K772013) received a 510(k) decision of Substantially Equivalent on October 28, 1977, 3 days after the submission was received.
What is the product code of K772013?
The FDA product code is HAO – Instrument, Surgical, Non-Powered, a Class I (low risk) device regulated under 21 CFR 882.4535.