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)

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON

K-Number: K860638 · 1986-10-01

ApplicantKontron Instruments, Inc.
Decision Date1986-10-01
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1986-10-01 under 510(k) number K860638. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON?

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON is a medical device that received FDA 510(k) clearance on 1986-10-01. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K860638.

When did NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON receive FDA 510(k) clearance?

NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON received FDA 510(k) clearance on 1986-10-01, under 510(k) number K860638.

Who is the listed applicant for NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON?

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

What is the FDA product code for NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON?

The FDA product code for NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON is DSP.

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 Kontron Instruments, 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.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM

View all 57 devices →

Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, 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.

↑