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FDA 510(k)

THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200

K-Number: K092175 · 2010-02-17

ApplicantFlowcardia, Inc.
Decision Date2010-02-17
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 is the device name listed in this FDA 510(k) record. The listed applicant is Flowcardia, Inc.. It received FDA 510(k) clearance on 2010-02-17 under 510(k) number K092175. 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 S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200?

THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 is a medical device that received FDA 510(k) clearance on 2010-02-17. The listed applicant is Flowcardia, Inc.. The 510(k) number is K092175.

When did THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 receive FDA 510(k) clearance?

THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 received FDA 510(k) clearance on 2010-02-17, under 510(k) number K092175.

Who is the listed applicant for THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200?

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 S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200?

The FDA product code for THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 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.

K090621FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100K091254THE CROSSER 14 OTW CATHETER, MODEL CRU014K091119MODIFICATION TO THE CROSSER SYSTEMK080849MICROSHEATH 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.

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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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