K934939 is an FDA 510(k) clearance for the 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, 583 days after receiving the submission on October 18, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K934939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1993 |
| Decision Date | May 24, 1995 |
| Days to Decision | 583 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 |