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FDA 510(k)

ACT 11 MP VENTRICULAR CATHETER

K-Number: K013005 · 2002-03-08

ApplicantInnerspace, Inc.
Decision Date2002-03-08
Product CodeHCA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACT 11 MP 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 2002-03-08 under 510(k) number K013005. The device is classified under product code HCA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACT 11 MP VENTRICULAR CATHETER?

ACT 11 MP VENTRICULAR CATHETER is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Innerspace, Inc.. The 510(k) number is K013005.

When did ACT 11 MP VENTRICULAR CATHETER receive FDA 510(k) clearance?

ACT 11 MP VENTRICULAR CATHETER received FDA 510(k) clearance on 2002-03-08, under 510(k) number K013005.

Who is the listed applicant for ACT 11 MP 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 11 MP VENTRICULAR CATHETER?

The FDA product code for ACT 11 MP VENTRICULAR CATHETER is HCA.

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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 CATHETERK010422ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER

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Related Devices (Code: HCA)

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.

K161731Cleveland Multiport Ventricular Catheter SetParker Hannifin Corp.K123605SMARTFLOW CATHETERMri Interventions, Inc.K031123CODMAN BACTISEAL BARIUM STRIPED CATHETERSCodman & Shurtleff, Inc.K021481BRESAGEN CATHETER, MODEL CS-3000Bresagen, Inc.K020728MIETHKE SHUNT SYSTEMAesculap, Inc.K003322CODMAN BACTISEAL CATHETERSCodman & Shurtleff, Inc.

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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