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FDA 510(k)

THE CROSSER SYSTEM

K-Number: K072776 · 2007-12-07

ApplicantFlowcardia, Inc.
Decision Date2007-12-07
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CROSSER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K072776. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CROSSER SYSTEM?

THE CROSSER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Flowcardia, Inc.. The 510(k) number is K072776.

When did THE CROSSER SYSTEM receive FDA 510(k) clearance?

THE CROSSER SYSTEM received FDA 510(k) clearance on 2007-12-07, under 510(k) number K072776.

Who is the listed applicant for THE CROSSER SYSTEM?

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

What is the FDA product code for THE CROSSER SYSTEM?

The FDA product code for THE CROSSER SYSTEM is PDU.

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Other records listing Flowcardia, 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.

K092175THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100K091254THE CROSSER 14 OTW CATHETER, MODEL CRU014K091119MODIFICATION TO THE CROSSER SYSTEMK080849MICROSHEATH LP AND LP-ATK080765CROSSER LP SYSTEM

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Related Devices (Code: PDU)

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.

K262013Kiba CTO Crossing CatheterReflow Medical, Inc.K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, 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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