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FDA 510(k)

MODIFICATION TO THE CROSSER SYSTEM

K-Number: K091119 · 2009-05-15

ApplicantFlowcardia, Inc.
Decision Date2009-05-15
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO 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 2009-05-15 under 510(k) number K091119. 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 MODIFICATION TO THE CROSSER SYSTEM?

MODIFICATION TO THE CROSSER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-15. The listed applicant is Flowcardia, Inc.. The 510(k) number is K091119.

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

MODIFICATION TO THE CROSSER SYSTEM received FDA 510(k) clearance on 2009-05-15, under 510(k) number K091119.

Who is the listed applicant for MODIFICATION TO 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 MODIFICATION TO THE CROSSER SYSTEM?

The FDA product code for MODIFICATION TO THE CROSSER SYSTEM is PDU.

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.

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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 CRU014K080849MICROSHEATH LP AND LP-ATK080765CROSSER LP SYSTEMK073289MICROSHEATH XL CATHETERS

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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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