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)

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE

K-Number: K070225 · 2007-12-13

ApplicantAbiomed, Inc.
Decision Date2007-12-13
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2007-12-13 under 510(k) number K070225. 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 SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE?

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE is a medical device that received FDA 510(k) clearance on 2007-12-13. The listed applicant is Abiomed, Inc.. The 510(k) number is K070225.

When did SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE receive FDA 510(k) clearance?

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE received FDA 510(k) clearance on 2007-12-13, under 510(k) number K070225.

Who is the listed applicant for SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE?

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

What is the FDA product code for SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE?

The FDA product code for SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE 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 Abiomed, 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.

K25276614Fr Low Profile Introducer KitK241708Abiomed 14Fr Low Profile Introducer KitK221294preCARDIA Occlusion SystemK223161OXY-1 SystemK222113Abiomed 14Fr Low Profile Introducer SetK202330Impella XR Sheath Set

View all 19 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.

↑