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FDA 510(k)

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER

K-Number: K010422 · 2001-06-28

ApplicantInnerspace, Inc.
Decision Date2001-06-28
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace, Inc.. It received FDA 510(k) clearance on 2001-06-28 under 510(k) number K010422. 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 ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER?

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Innerspace, Inc.. The 510(k) number is K010422.

When did ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER receive FDA 510(k) clearance?

ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER received FDA 510(k) clearance on 2001-06-28, under 510(k) number K010422.

Who is the listed applicant for ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER?

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

What is the FDA product code for ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER?

The FDA product code for ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER is GWM.

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Other records listing Innerspace, 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.

K113088HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)K083378SYNERGYK072379MPS OXIPORT AND MPS OXIPORT PLUSK041838MPS (OR MPS-T)K013705ACT III VENTRICULAR CATHETERK013005ACT 11 MP VENTRICULAR CATHETER

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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.

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