H-H Shunt Passers
FDA 510(k) K841553 · Holter-Hausner Intl.
510(k) numberK841553
Submission
- Device name
- H-H Shunt Passers
- Applicant
- Holter-Hausner Intl.
Mchenry, IL, US - Received
- April 16, 1984
- Decision date
- May 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GYK
| 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 |
More from Holter-Hausner Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K875287 | H-H Flushing ReservoirJXG · Traditional | 07/14/1988SE |
| K874508 | H-H External Ventricular Drainage Collection BagJXG · Traditional | 01/19/1988SE |
| K872293 | H-H Hunter Active Tendon Implant BCHXA · Traditional | 09/28/1987SN |
| K872285 | H-H Hunter Active Tendon Implant DCHXA · Traditional | 09/28/1987SN |
| K872284 | H-H Hunter Active Tendon Implant PCHXA · Traditional | 09/28/1987SN |
| K871351 | H-H Harris Neonatal Nasal Cannula Set for CPAPBZD · Traditional | 05/14/1987SE |
| K870660 | H-H External Ventricular Drain (Evd) Comp./SystemsJXG · Traditional | 05/01/1987SE |
| K865075 | H-H Subgaleal TrocarGYK · Traditional | 01/13/1987SE |
| K853437 | H-H Hunter Tendon Rod · Traditional | 10/16/1985SE |
| K853436 | H-H Hunter Passive Tendon ImplantHXR · Traditional | 10/16/1985SE |
Questions and answers
When was H-H Shunt Passers cleared by the FDA?
H-H Shunt Passers (K841553) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 28 days after the submission was received.
What is the product code of K841553?
The FDA product code is GYK – Instrument, Shunt System Implantation, a Class I (low risk) device regulated under 21 CFR 882.4545.