K883607 is an FDA 510(k) clearance for the PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER. This device is classified as a Instrument, Shunt System Implantation (Class I - General Controls, product code GYK).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on September 30, 1988, 38 days after receiving the submission on August 23, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4545.
| 510(k) Number | K883607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 1988 |
| Decision Date | September 30, 1988 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | GYK - Instrument, Shunt System Implantation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 882.4545 |