510(k) K811288 ยท JXG Shunt, Central Nervous System And Components
SPETZLER LUMBAR-PERITONEAL SYSTEM
| Applicant | American Heyer Schulte, Mchenry IL, US |
| Decision | Substantially Equivalent, Jun 26, 1981 |
| Received | May 11, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***"
Stainless steel stylet for ventr Terminated |
JXG | None listed |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14 g, 3.5"***Plainsboro, NJ***"
Needle for lumbar peritoneal shunt Terminated |
JXG | None listed |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use Only***Plainsboro, NJ***"
Collars for lumbar peritoneal shunt Terminated |
JXG | None listed |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Only***14g, 6"***Plainsboro, NJ***"
Needle for lumbar peritoneal shunt Terminated |
JXG | None listed |
| Feb 16, 2012 | Integra Neurosciences PR, Inc. "***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single Use Only***Small OD .047", Large OD .058"***Plainsboro, NJ***"
Step down connector to be secure with ligature Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.