K780579 is an FDA 510(k) clearance for the SUBCUPASS TUNNELING TOOL. This device is classified as a Instrument, Surgical, Non-powered (Class I - General Controls, product code HAO).
Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 19, 1978, 39 days after receiving the submission on April 10, 1978.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4535.
| 510(k) Number | K780579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1978 |
| Decision Date | May 19, 1978 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HAO — Instrument, Surgical, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4535 |