FDA Product Code
FDA Product Code GYK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.4545
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962761 | REIGEL TUNNELING DEVICE | Cook, Inc. | 1996-10-11 | Traditional | PDF ↗ |
| K934391 | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | 1993-09-10 | Traditional | PDF ↗ |
| K932273 | CORDIS TUNNELER | Cordis Corp. | 1993-08-23 | Traditional | PDF ↗ |
| K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Baxter Healthcare Corp | 1989-10-31 | Traditional | PDF ↗ |
| K883607 | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Codman & Shurtleff, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | American V. Mueller | 1987-12-18 | Traditional | PDF ↗ |
| K865075 | H-H SUBGALEAL TROCAR | Holter-Hausner Intl. | 1987-01-13 | Traditional | PDF ↗ |
| K853370 | H-H CATHETER PASSERS(TACL DESIGN | Holter-Hausner Intl. | 1985-09-18 | Traditional | PDF ↗ |
| K853368 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | 1985-09-06 | Traditional | PDF ↗ |
| K841553 | H-H SHUNT PASSERS | Holter-Hausner Intl. | 1984-05-14 | Traditional | PDF ↗ |
| K792639 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | 1979-12-31 | Traditional | PDF ↗ |
| K771529 | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | 1977-08-16 | Traditional | PDF ↗ |
Product code GYK · Class I · Neurology. Data: openFDA.