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FDA 510(k)

PRESSUREWIRE SENSOR, MODEL #12001

K-Number: K983506 · 1999-02-03

ApplicantRadi Medical Systems AB
Decision Date1999-02-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSUREWIRE SENSOR, MODEL #12001 is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 1999-02-03 under 510(k) number K983506. 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 PRESSUREWIRE SENSOR, MODEL #12001?

PRESSUREWIRE SENSOR, MODEL #12001 is a medical device that received FDA 510(k) clearance on 1999-02-03. The listed applicant is Radi Medical Systems AB. The 510(k) number is K983506.

When did PRESSUREWIRE SENSOR, MODEL #12001 receive FDA 510(k) clearance?

PRESSUREWIRE SENSOR, MODEL #12001 received FDA 510(k) clearance on 1999-02-03, under 510(k) number K983506.

Who is the listed applicant for PRESSUREWIRE SENSOR, MODEL #12001?

The FDA 510(k) record lists Radi Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSUREWIRE SENSOR, MODEL #12001?

The FDA product code for PRESSUREWIRE SENSOR, MODEL #12001 is DQX.

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Other records listing Radi Medical Systems AB 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.

K123984QUANTIEN MEASUREMENT SYSTEMK092105RADIANALYZER XPRESSK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711

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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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