K102101 is an FDA 510(k) clearance for the SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA. This device is classified as a Cannula, Ventricular (Class I - General Controls, product code HCD).
Submitted by Surgivision, Inc. (Irvine, US). The FDA issued a Cleared decision on January 26, 2011, 183 days after receiving the submission on July 27, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4060.
| 510(k) Number | K102101 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2010 |
| Decision Date | January 26, 2011 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCD — Cannula, Ventricular |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4060 |