Instrument, Shunt System Implantation
FDA product code GYK · Class I (low risk) · 21 CFR 882.4545 · Neurology
13510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962761 | Reigel Tunneling DeviceGYK · Traditional | Cook, Inc. | 10/11/1996SE |
| K934391 | V/P and L/P Catheter PassersGYK · Traditional | Radionics, Inc. | 11/19/1993SE |
| K930606 | PS Medical Disposable Subcutaneous Cath PasserGYK · Traditional | Pudenz-Schulte Medical Research Corp. | 09/10/1993SE |
| K932273 | Cordis TunnelerGYK · Traditional | Cordis Corp. | 08/23/1993SE |
| K895868 | Heyer-Schulte Disposable Peritoneal Catheter PasseGYK · Traditional | Baxter Healthcare Corp | 10/31/1989SE |
| K883607 | Peel-Away Introducer for Ventricular CatheterGYK · Traditional | Codman & Shurtleff, Inc. | 09/30/1988SE |
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | American V. Mueller | 12/18/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | Holter-Hausner Intl. | 01/13/1987SE |
| K853370 | H-H Catheter Passers(Tacl DesignGYK · Traditional | Holter-Hausner Intl. | 09/18/1985SE |
| K853368 | H-H Shunt IntroducerGYK · Traditional | Holter-Hausner Intl. | 09/06/1985SE |
| K841553 | H-H Shunt PassersGYK · Traditional | Holter-Hausner Intl. | 05/14/1984SE |
| K792639 | H-H Shunt IntroducerGYK · Traditional | Holter-Hausner Intl. | 12/31/1979SE |
| K771529 | Peritoneal Introducer & SheathGYK · Traditional | Cordis Corp. | 08/16/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1231-2011 | Integra Peritoneal Introducer Sheaths, 61 cm;Integra NeuroSciences/REF 901-124…Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm. | Integra LifeSciences Corp. | 12/22/2010Terminated |