K945413 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT. This device is classified as a Catheter, Percutaneous, Intraspinal, Short Term (Class II - Special Controls, product code MAJ).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 24, 1995, 202 days after receiving the submission on November 3, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K945413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1994 |
| Decision Date | May 24, 1995 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MAJ — Catheter, Percutaneous, Intraspinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |