510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PCBClass II

External Cerebrospinal Fluid (Csf) Diversion

21 CFR 882.5560 / Neurology
FDA source (opens on fda.gov)

PCB is the FDA product code for External Cerebrospinal Fluid (Csf) Diversion, a class II device type, regulated under 21 CFR 882.5560. FDA's definition for this code reads: "Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
PCB
Device name
External Cerebrospinal Fluid (Csf) Diversion
FDA definition
Cerebrospinal fluid (CSF) diversion intended to alter spinal cord perfusion.
Regulation
21 CFR 882.5560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
5

Clearances, product code PCB

By decision year
2 clearances under product code PCB with a decision year between 2014 and 2024, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PCB by decision year
YearClearances
20141
20241

Applicants with the most clearances

Product code PCB
Applicants holding the most 510(k) clearances under product code PCB
ApplicantClearances
Medtronic Neurosurgery2

Companies listing this code with FDA

Companies whose registered establishments list this code