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FDA 510(k)

SMARTWIRE/SMARTMAP PRESSURE SYSTEM

K-Number: K021219 · 2002-05-17

ApplicantJomed, Inc.
Decision Date2002-05-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTWIRE/SMARTMAP PRESSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Jomed, Inc.. It received FDA 510(k) clearance on 2002-05-17 under 510(k) number K021219. 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 SMARTWIRE/SMARTMAP PRESSURE SYSTEM?

SMARTWIRE/SMARTMAP PRESSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-17. The listed applicant is Jomed, Inc.. The 510(k) number is K021219.

When did SMARTWIRE/SMARTMAP PRESSURE SYSTEM receive FDA 510(k) clearance?

SMARTWIRE/SMARTMAP PRESSURE SYSTEM received FDA 510(k) clearance on 2002-05-17, under 510(k) number K021219.

Who is the listed applicant for SMARTWIRE/SMARTMAP PRESSURE SYSTEM?

The FDA 510(k) record lists Jomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTWIRE/SMARTMAP PRESSURE SYSTEM?

The FDA product code for SMARTWIRE/SMARTMAP PRESSURE SYSTEM is DQX.

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Other records listing Jomed, 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.

K031346JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900K031148IN-VISION IMAGING SYSTEMK031277JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002K022762JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050K003938TRAK BACK II

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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