Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys
FDA 510(k) K871685 · American V. Mueller
510(k) numberK871685
Submission
- Device name
- Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys
- Applicant
- American V. Mueller
Chicago, IL, US - Received
- April 29, 1987
- Decision date
- June 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JXG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261004 | Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER®…JXG · Traditional | Integra Lifesciences Production Corporation | 06/23/2026SE |
| K251598 | IntellidropJXG · Traditional | Brainspace, Inc. | 12/10/2025SE |
| K250636 | Sophy Mini Monopressure Valve (SM1)JXG · Traditional | Sophysa | 11/28/2025SE |
| K252514 | Evac-MriJXG · Traditional | Phasor Health, LLC | 11/05/2025SESD |
| K243531 | Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG · Traditional | Integra Lifesciences Production Corporation | 08/08/2025SE |
| K243552 | Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…JXG · Traditional | Integra Lifesciences Production Corporation | 08/06/2025SE |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG · Traditional | Sophysa | 06/20/2025SE |
| K243205 | EvacJXG · Traditional | Phasor Health, LLC | 06/03/2025SE |
| K243676 | Duet External Drainage and Monitoring System (EDMS)JXG · Traditional | Medtronic Neurosurgery | 03/10/2025SE |
| K242003 | XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetJXG · Traditional | Aesculap, Inc. | 12/16/2024SE |
More from Aesculap, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K873771 | Heyer-Schulte(R) One Piece Shunt Vent. Cath. IntroGYK · Traditional | 12/18/1987SE |
| K873332 | Maxivac(Tm) Closed Wound Suction Drainage SystemGCY · Traditional | 09/08/1987SE |
| K864676 | Heyer-Schulte Hermetic External CSF Drain. SystemJXG · Traditional | 12/29/1986SE |
| K862772 | V. Mueller (R) Gooseneck Circular StaplerGAG · Traditional | 08/18/1986SE |
| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
| K854568 | V. Mueller Pneumo-Intestinal 15 Vascular & 30 StapGEF · Traditional | 12/02/1985SE |
| K854049 | Heyer-Schulte Syringo Peritoneal ShuntJXG · Traditional | 11/27/1985SE |
| K851082 | V. Mueller Blom-Singer Esophageal Insufflation TesENW · Traditional | 07/22/1985SE |
| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
| K850947 | V-Mueller Inverted Linear Anastomosis InstrumentsGAG · Traditional | 04/17/1985SE |
Questions and answers
When was Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys cleared by the FDA?
Heyer-Schulte Spetzler Lumbar-Peritoneal Shunt Sys (K871685) received a 510(k) decision of Substantially Equivalent on June 12, 1987, 44 days after the submission was received.
What is the product code of K871685?
The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.