Atlas FDA

HEYER-SCHULTE SYRINGO PERITONEAL SHUNT

FDA 510(k) clearance K854049 · decided 1985-11-27

Clearance details

K-number
K854049
Device name
HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
Applicant
American V. Mueller
Decision
Substantially Equivalent
Date received
1985-10-03
Decision date
1985-11-27
Days to decision
55 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Chicago, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile recall (Z-1047-201)Integra Neurosciences PR, Inc.2012-02-16
"***REF NL82059-01***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Onl recall (Z-1048-2012)Integra Neurosciences PR, Inc.2012-02-16
"***REF NL82059-02***INTEGRA NEUROSCIENCES***Suture Collars***Non Sterile for Single Use O recall (Z-1049-2012)Integra Neurosciences PR, Inc.2012-02-16
"***REF NL82059-03***INTEGRA NEUROSCIENCES***Touhy Needle***Non Sterile for Single Use Onl recall (Z-1050-2012)Integra Neurosciences PR, Inc.2012-02-16
"***REF NL86004-01***INTEGRA NEUROSCIENCES***Step Down Connector***Non Sterile for Single recall (Z-1051-2012)Integra Neurosciences PR, Inc.2012-02-16