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FDA 510(k)

Route 92 Medical Sheath System

K-Number: K191717 · 2020-01-13

ApplicantRoute 92 Medical, Inc.
Decision Date2020-01-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2020-01-13 under 510(k) number K191717. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Route 92 Medical Sheath System?

Route 92 Medical Sheath System is a medical device that received FDA 510(k) clearance on 2020-01-13. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K191717.

When did Route 92 Medical Sheath System receive FDA 510(k) clearance?

Route 92 Medical Sheath System received FDA 510(k) clearance on 2020-01-13, under 510(k) number K191717.

Who is the listed applicant for Route 92 Medical Sheath System?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Route 92 Medical Sheath System?

The FDA product code for Route 92 Medical Sheath System is DQY.

Other records listing Route 92 Medical, 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.

K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetK2405298F Modified Sheath SystemK233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetK231583Route 92 Medical Full Length 054 Access SystemK223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetK222743Route 92 Medical Full Length 070 Access System

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Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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