Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PARENCHYMAL BOLT PRESSURE MONITORING KIT

K-Number: K981846 · 1998-08-18

ApplicantCamino Neurocare, Inc.
Decision Date1998-08-18
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PARENCHYMAL BOLT PRESSURE MONITORING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Camino Neurocare, Inc.. It received FDA 510(k) clearance on 1998-08-18 under 510(k) number K981846. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARENCHYMAL BOLT PRESSURE MONITORING KIT?

PARENCHYMAL BOLT PRESSURE MONITORING KIT is a medical device that received FDA 510(k) clearance on 1998-08-18. The listed applicant is Camino Neurocare, Inc.. The 510(k) number is K981846.

When did PARENCHYMAL BOLT PRESSURE MONITORING KIT receive FDA 510(k) clearance?

PARENCHYMAL BOLT PRESSURE MONITORING KIT received FDA 510(k) clearance on 1998-08-18, under 510(k) number K981846.

Who is the listed applicant for PARENCHYMAL BOLT PRESSURE MONITORING KIT?

The FDA 510(k) record lists Camino Neurocare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PARENCHYMAL BOLT PRESSURE MONITORING KIT?

The FDA product code for PARENCHYMAL BOLT PRESSURE MONITORING KIT is GWM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Camino Neurocare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K982702VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SDK962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)

Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑