FDA 510(k)

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE

K-Number: K972793 · 1998-04-24

Decision Date1998-04-24

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE 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 1998-04-24 under 510(k) number K972793. 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 PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE?

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Radi Medical Systems AB. The 510(k) number is K972793.

When did PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE receive FDA 510(k) clearance?

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE received FDA 510(k) clearance on 1998-04-24, under 510(k) number K972793.

Who is the listed applicant for PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE?

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 PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE?

The FDA product code for PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE is DQX.

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Other records listing Radi Medical Systems AB as applicant

K123984QUANTIEN MEASUREMENT SYSTEM K092105RADIANALYZER XPRESS K080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER K080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM K062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 K042628MODIFICATION TO: RADIANALYZER, MODEL 12711

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Related Devices (Code: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K261640Merit 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.