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)

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM

K-Number: K103003 · 2010-11-09

ApplicantAesculap, Inc.
Decision Date2010-11-09
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K103003. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM?

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Aesculap, Inc.. The 510(k) number is K103003.

When did AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM receive FDA 510(k) clearance?

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM received FDA 510(k) clearance on 2010-11-09, under 510(k) number K103003.

Who is the listed applicant for AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM?

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

What is the FDA product code for AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM?

The FDA product code for AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM is JXG.

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 Aesculap, 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.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

View all 195 devices →

Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra 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.

↑