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FDA 510(k)

Wattson Temporary Pacing Guidewire

K-Number: K192454 · 2020-01-15

ApplicantVascular Solutions
Decision Date2020-01-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wattson Temporary Pacing Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions. It received FDA 510(k) clearance on 2020-01-15 under 510(k) number K192454. 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 Wattson Temporary Pacing Guidewire?

Wattson Temporary Pacing Guidewire is a medical device that received FDA 510(k) clearance on 2020-01-15. The listed applicant is Vascular Solutions. The 510(k) number is K192454.

When did Wattson Temporary Pacing Guidewire receive FDA 510(k) clearance?

Wattson Temporary Pacing Guidewire received FDA 510(k) clearance on 2020-01-15, under 510(k) number K192454.

Who is the listed applicant for Wattson Temporary Pacing Guidewire?

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

What is the FDA product code for Wattson Temporary Pacing Guidewire?

The FDA product code for Wattson Temporary Pacing Guidewire is DQX.

Other records listing Vascular Solutions 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.

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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.

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.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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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