GYK · Instrument, Shunt System Implantation
Neurology · 21 CFR 882.4545 · Class 1
Overview
| Product Code | GYK |
|---|---|
| Device Name | Instrument, Shunt System Implantation |
| Regulation | 21 CFR 882.4545 |
| Device Class | Class 1 |
| Review Panel | Neurology |
Identification
A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962761 | REIGEL TUNNELING DEVICE | Cook, Inc. | Oct 11, 1996 | SESE |
| K934391 | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | Nov 19, 1993 | SESE |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | Sep 10, 1993 | SESE |
| K932273 | CORDIS TUNNELER | Cordis Corp. | Aug 23, 1993 | SESE |
| K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Baxter Healthcare Corp | Oct 31, 1989 | SESE |
| K883607 | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Codman & Shurtleff, Inc. | Sep 30, 1988 | SESE |
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | American V. Mueller | Dec 18, 1987 | SESE |
| K865075 | H-H SUBGALEAL TROCAR | Holter-Hausner Intl. | Jan 13, 1987 | SESE |
| K853370 | H-H CATHETER PASSERS(TACL DESIGN | Holter-Hausner Intl. | Sep 18, 1985 | SESE |
| K853368 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | Sep 6, 1985 | SESE |
| K841553 | H-H SHUNT PASSERS | Holter-Hausner Intl. | May 14, 1984 | SESE |
| K792639 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | Dec 31, 1979 | SESE |
| K771529 | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | Aug 16, 1977 | SESE |
Top Applicants
- Holter-Hausner Intl. — 5 clearances
- Cordis Corp. — 2 clearances
- American V. Mueller — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Codman & Shurtleff, Inc. — 1 clearance
