510(k) K853368
- Device
- H-H SHUNT INTRODUCER
- Applicant
- HOLTER-HAUSNER INTL.
- 510(k) number
- K853368
- Product code
- GYK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-06
- Date received
- 1985-08-12
- Regulation
- 882.4545
- Classification name
- Instrument, Shunt System Implantation
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN R BOLLES
- Address
- Third And Mill St.S P.O. Box 100 Bridgeport PA US 19405 19405
FDA Registration Numbers#
- 3014334038
- 3009662890
- 2023988
- 2648988
- 1836161
- 8040278
- 3015531529
- 3004721439
- 1923569
- 3003477135
- 2916714
- 3007156625
- 1424263
- 1220477
- 3018094310
- 8030607
- 3003418325
- 3006240422
- 9610612
- 3001587388
- 3015462837
- 3015972835
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GYK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962761 | REIGEL TUNNELING DEVICE | Cook, Inc. | 1996-10-11 |
| K934391 | V/P AND L/P CATHETER PASSERS | Radionics, Inc. | 1993-11-19 |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Pudenz-Schulte Medical Research Corp. | 1993-09-10 |
| K932273 | CORDIS TUNNELER | Cordis Corp. | 1993-08-23 |
| K895868 | HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE | Baxter Healthcare Corp | 1989-10-31 |
| K883607 | PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER | Codman & Shurtleff, Inc. | 1988-09-30 |
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | American V. Mueller | 1987-12-18 |
| K865075 | H-H SUBGALEAL TROCAR | Holter-Hausner Intl. | 1987-01-13 |
| K853370 | H-H CATHETER PASSERS(TACL DESIGN | Holter-Hausner Intl. | 1985-09-18 |
| K841553 | H-H SHUNT PASSERS | Holter-Hausner Intl. | 1984-05-14 |
| K792639 | H-H SHUNT INTRODUCER | Holter-Hausner Intl. | 1979-12-31 |
| K771529 | PERITONEAL INTRODUCER & SHEATH | Cordis Corp. | 1977-08-16 |
Legacy Summary#
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FDA Review#
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