Instrument, Shunt System Implantation
Neurology · 21 CFR 882.4545
Recent MDR events
15 adverse event reports on file
- TUNNELER 600MM RIGIDDec 1, 2025MalfunctionChristoph Miethke Gmbh & Co Kg3004721439-2025-00352
- 12.5 FR (4.2 MM) (.166 IN.) PEEL-AWAY CATHETER INTRODUCERSep 15, 2022InjuryRaynham3014334038-2022-00205
- CODMANAug 26, 2022MalfunctionIntegra Lifesciences Production Corporation15300221
- SHUNT TUNNELERMar 25, 2022InjuryIntegra Neuroscicencs Implants Sa9612007-2022-00008
- SHUNT TUNNELERMar 3, 2022MalfunctionIntegra Neuroscicencs Implants Sa9612007-2022-00006
- SHEATH, PERITONEAL INTRODUCER, 46CM - BOX OF 5May 27, 2020MalfunctionNatus Medical Incorporated2023988-2020-00013
- CATHETER PASSER, DISPOSABLE, 38 CMMar 24, 2017MalfunctionMedtronic Neurosurgery6431590
- PERITONEAL INTRODUCER SHEATHS 70CMSep 29, 2016MalfunctionIntegra Neuroscicencs Implants Sa9612007-2016-00038
- CATHETER PASSER 60CMJan 19, 2016MalfunctionMedtronicMW5059939
- HOFF PASS-LONGMay 15, 2014InjuryCodman & Shurtleff1226348-2014-11630
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
32 firms currently registered for this product code
Integra Lifesciences Corporation
Princeton, NJ, US
American Benchmark Machine Works
Olympia, WA, US
Christoph Miethke Gmbh & Co.kg
potsdam Brandenburg, DE
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Sophysa
BESANCON Doubs, FR
Sterigenics Sas
Rantigny Oise, FR
Integra Neurosciences
ANASCO, PR, US
Natus Medical Incorporated
SAN DIEGO, CA, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Sophysa
ORSAY, CEDEX Essonne, FR
Isomedix Operations Inc.
Northborough, MA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Quality Tech Services, Llc
Bloomington, MN, US
Christoph Miethke Gmbh & Co.kg
potsdam Brandenburg, DE
Integra Lifesciences Production Corporation
Mansfield, MA, US
510(k) clearances
13 clearances for this product code
- Cook, Inc.Oct 11, 1996
K962761 · REIGEL TUNNELING DEVICE
- Radionics, Inc.Nov 19, 1993
K934391 · V/P AND L/P CATHETER PASSERS
- Pudenz-Schulte Medical Research Corp.Sep 10, 1993
K930606 · PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
- Cordis Corp.Aug 23, 1993
K932273 · CORDIS TUNNELER
- Baxter Healthcare CorpOct 31, 1989
K895868 · HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE
- Codman & Shurtleff, Inc.Sep 30, 1988
K883607 · PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
- American V. MuellerDec 18, 1987
K873771 · HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO
- Holter-Hausner Intl.Jan 13, 1987
K865075 · H-H SUBGALEAL TROCAR