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FDA 510(k)

Endophys Pressure Sensing Sheath Kit

K-Number: K180620 · 2018-10-12

ApplicantEndophys Holdings, LLC
Decision Date2018-10-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endophys Pressure Sensing Sheath Kit is the device name listed in this FDA 510(k) record. The listed applicant is Endophys Holdings, LLC. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K180620. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Endophys Pressure Sensing Sheath Kit?

Endophys Pressure Sensing Sheath Kit is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Endophys Holdings, LLC. The 510(k) number is K180620.

When did Endophys Pressure Sensing Sheath Kit receive FDA 510(k) clearance?

Endophys Pressure Sensing Sheath Kit received FDA 510(k) clearance on 2018-10-12, under 510(k) number K180620.

Who is the listed applicant for Endophys Pressure Sensing Sheath Kit?

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

What is the FDA product code for Endophys Pressure Sensing Sheath Kit?

The FDA product code for Endophys Pressure Sensing Sheath Kit is DYB.

Other records listing Endophys Holdings, LLC 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.

K190098Endophys Pressure Sensing SheathK173399Endophys Pressure Sensing Sheath Kit- 8FK160945Endophys Blood Pressure Monitor

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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