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FDA 510(k)

CROSSER LP SYSTEM

K-Number: K080765 · 2008-06-20

ApplicantFlowcardia, Inc.
Decision Date2008-06-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CROSSER LP 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 2008-06-20 under 510(k) number K080765. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROSSER LP SYSTEM?

CROSSER LP SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Flowcardia, Inc.. The 510(k) number is K080765.

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

CROSSER LP SYSTEM received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080765.

Who is the listed applicant for CROSSER LP 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 CROSSER LP SYSTEM?

The FDA product code for CROSSER LP SYSTEM is DQX.

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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-ATK073289MICROSHEATH XL CATHETERS

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Related Devices (Code: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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